Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT03355820
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2017-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'At Day 1', 'description': 'There were no adverse events (AEs) data collected during the entire study period (i.e. at Day 1).\n\nOnly 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).', 'eventGroups': [{'id': 'EG000', 'title': 'HPV Group', 'description': '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 227, 'otherNumAffected': 0, 'seriousNumAtRisk': 227, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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)', 'description': '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-HPV-16 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1236.3', 'groupId': 'OG000', 'lowerLimit': '1121.8', 'upperLimit': '1362.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', '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)', 'description': 'Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Anti-HPV-18 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '535.6', 'groupId': 'OG000', 'lowerLimit': '478.6', 'upperLimit': '599.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', '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)', 'description': 'Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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', 'description': '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.\n\nThe 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.\n\nData corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.\n\nData 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\\]").', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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', 'description': '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.\n\nThe 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.\n\nData corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.\n\nData 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\\]).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Concentration of Antibodies Against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1236.3', 'groupId': 'OG000', 'lowerLimit': '1121.8', 'upperLimit': '1362.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', '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', 'description': 'Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.\n\nAnti-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.\n\nData corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.\n\nData 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\\]").', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Concentration of Antibodies Against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV Group', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '535.6', 'groupId': 'OG000', 'lowerLimit': '478.6', 'upperLimit': '599.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', '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', 'description': 'Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.\n\nAnti-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.\n\nData corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.\n\nData 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\\]").', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HPV Group', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at a single center in China.', 'preAssignmentDetails': '228 subjects were included in the Enrolled Set, 1 subject was excluded from all statistical analyses, thus 227 subjects formed the Exposed Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HPV Group', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '2.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '227', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-19', 'size': 2731626, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-03T15:33', 'hasProtocol': True}, {'date': '2018-03-21', 'size': 421829, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-03T15:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-27', 'studyFirstSubmitDate': '2017-11-22', 'resultsFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-03', 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'description': '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).'}, {'measure': '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)', 'description': '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.'}, {'measure': '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)', 'description': 'Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.'}, {'measure': '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)', 'description': 'Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.'}], 'secondaryOutcomes': [{'measure': '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', 'description': '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.\n\nThe 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.\n\nData corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.\n\nData 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\\]").'}, {'measure': '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', 'description': '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.\n\nThe 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.\n\nData corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.\n\nData 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\\]).'}, {'measure': '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', 'description': 'Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.\n\nAnti-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.\n\nData corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.\n\nData 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\\]").'}, {'measure': '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', 'description': 'Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.\n\nAnti-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.\n\nData corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.\n\nData 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\\]").'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune response', 'Cervarix', 'Persistence', 'Chinese', 'Human papillomavirus'], 'conditions': ['Cervical Intraepithelial Neoplasia']}, 'referencesModule': {'references': [{'pmid': '32780946', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* Written informed consent obtained from the subject or subject's parents/LAR(s) prior to performing any study specific procedure.\n* Written informed assent obtained from the subjects below the legal age of consent.\n* Subjects who received all three doses of the HPV-16/18 vaccine in the HPV-058 study.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n\nExclusion Criteria:\n\n* 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.\n* 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).\n* Previous vaccination against HPV outside the HPV-058 study.\n* Subjects with contraindications related to blood draw such as blood disorders and anticoagulants use."}, 'identificationModule': {'nctId': 'NCT03355820', 'briefTitle': "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", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects From the HPV-058 Study", 'orgStudyIdInfo': {'id': '207347'}, 'secondaryIdInfos': [{'id': '2017-000255-50', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPV Group', 'description': '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.', 'interventionNames': ['Procedure: Blood sampling for antibody determination']}], 'interventions': [{'name': 'Blood sampling for antibody determination', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['HPV Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225300', 'city': 'Taizhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20720', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)', 'ipdSharing': 'YES', 'description': 'IPD for this study is available via the Clinical Study Data Request site.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}