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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000255-50 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Group | Experimental | Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling for antibody determination | Procedure | In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (~5 mL) will be taken from all the subjects, at Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study | A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL). | 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 | A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL. | 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 | Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. | 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 | Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 38, Row "≥19 EL.U/mL, sero-, [Month 72]" and Row "≥19 EL.U/mL, sero+, [Month 72]"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Taizhou | Jiangsu | 225300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32780946 | Background | Hu Y, Zhang X, He 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, 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 Dec;16(6):392-399. doi: 10.1111/ajco.13398. Epub 2020 Aug 11. |
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IPD for this study is available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
228 subjects were included in the Enrolled Set, 1 subject was excluded from all statistical analyses, thus 227 subjects formed the Exposed Set.
This study was conducted at a single center in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | HPV Group | Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2017 | May 3, 2019 |
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| 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 | A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 39, Row "≥ 18 EL.U/mL, sero- [Month 72]" and Row "≥ 18 EL.U/mL, sero+ [Month 72]). | 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 | Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-16 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-16 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-16, sero-, [Month 72]" and Row "HPV-16, sero+, [Month 72]"). | 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 | Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-18 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-18 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-18, sero-, [Month 72]" and Row "HPV-18, sero+, [Month 72]"). | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HPV Group | Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study | A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL). | The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point. | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) Study | A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL. | The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point. | Posted | Count of Participants | Participants | 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) |
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| Primary | Anti-HPV-16 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study | Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | 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) |
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| Primary | Anti-HPV-18 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study | Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL. | The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | 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) |
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| Secondary | 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 | A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 38, Row "≥19 EL.U/mL, sero-, [Month 72]" and Row "≥19 EL.U/mL, sero+, [Month 72]"). | The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 38 in NCT00779766 record. | Posted | Count of Participants | Participants | 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 |
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| Secondary | 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 | A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL. The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 39, Row "≥ 18 EL.U/mL, sero- [Month 72]" and Row "≥ 18 EL.U/mL, sero+ [Month 72]). | The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 39 in NCT00779766 record. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Concentration of Antibodies Against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies | Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-16 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-16 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-16, sero-, [Month 72]" and Row "HPV-16, sero+, [Month 72]"). | The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 40 in NCT00779766 record. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | 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 |
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| Secondary | Concentration of Antibodies Against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies | Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL. Anti-HPV-18 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-18 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6. Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure. Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-18, sero-, [Month 72]" and Row "HPV-18, sero+, [Month 72]"). | The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 40 in NCT00779766 record. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | 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 |
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At Day 1
There were no adverse events (AEs) data collected during the entire study period (i.e. at Day 1).
Only SAEs related to study procedures or concomitant GSK medications/vaccines and events with a fatal outcome were recorded and collected during the entire study period (i.e. at Day 1).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HPV Group | Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study. | 0 | 227 | 0 | 227 | 0 | 0 |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2018 | May 3, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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