Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-15 @ 2:47 PM
Study NCT ID:
NCT00937950
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2009-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, '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': 'AEs and SAEs: From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study].', 'description': 'Non-serious AEs were not collected in this study. Only fatal SAEs, SAEs related to study participation, SAEs related to a concurrent GSK medication and AEs and SAEs leading to withdrawal from the study were collected in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 2003, 'otherNumAffected': 0, 'seriousNumAtRisk': 2003, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Positive DNA (Month 12 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '615', 'groupId': 'OG000'}]}]}, {'title': 'Negative DNA (Month 12 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '828', 'groupId': 'OG000'}]}]}, {'title': 'Missing DNA (Month 12 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Positive DNA (Month 24 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '869', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '418', 'groupId': 'OG000'}]}]}, {'title': 'Negative DNA (Month 24 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '869', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '444', 'groupId': 'OG000'}]}]}, {'title': 'Missing DNA (Month 24 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '869', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Positive DNA (Month 36 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}]}]}, {'title': 'Negative DNA (Month 36 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}]}]}, {'title': 'Missing DNA (Month 36 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Positive DNA (Month 48 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}, {'title': 'Negative DNA (Month 48 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Missing DNA (Month 48 Post HPV-008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 12, 24, 36, 48', 'description': 'Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68.\n\nMissing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Colposcopy Referral and Colposcopy Adequacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Colposcopy referral (Month 12) Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '572', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 12) No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1429', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 12) Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 12) Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '371', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 12) No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month12),Satisfactory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '370', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month12), Unsatisfactory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month 12), Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 24) Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '385', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 24) No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1615', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 24) Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 24) Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 24) No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 24) Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month24), Satisfactory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy(Month24),Unsatisfactory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month 24), Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 36) Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 36) No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1776', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 36) Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 36) Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 36) No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month36), Satisfactory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy(Month36), Unsatisfactory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month 36), Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 48) Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 48) No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1867', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy referral (Month 48) Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 48) Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': 'Algorithm respected (Month 48) No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month48), Satisfactory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month48), Unsatisfactory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Colposcopy adequacy (Month 48), Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 12, 24, 36, 48', 'description': "Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of ≥ atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of ≥ low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Normal, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1193', 'groupId': 'OG000'}]}]}, {'title': 'ASC-US, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'ASC-H, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'LSIL, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'HSIL, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'AGC, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1467', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Normal, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '867', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '662', 'groupId': 'OG000'}]}]}, {'title': 'ASC-US, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '867', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}, {'title': 'ASC-H, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '867', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'LSIL, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '867', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'HSIL, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '867', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'AGC, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '867', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Normal, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}]}]}, {'title': 'ASC-US, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'ASC-H, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'LSIL, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'HSIL, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'AGC, Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Normal, Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}, {'title': 'ASC-US, Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'ASC-H, Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'LSIL, Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'HSIL, Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'AGC, Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 12, 24, 36, 48', 'description': 'Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.\n\nCervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects with available data at the considered time points and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Cervical Biopsy Results at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN1(positive)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN1(negative)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN2 (positive)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN2 (negative)', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN3 (positive)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN3 (negative)', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 (positive)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2(negative)', 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN3(positive)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}]}]}, {'title': 'CIN2 and CIN3 (positive)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CIN2 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 and CIN3 (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}]}]}, {'title': 'AIS (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AIS (negative)', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}]}]}, {'title': 'Invasive malignancy (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Invasive malignancy (negative)', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 12', 'description': 'Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.\n\nCIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.\n\nNote: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Cervical Biopsy Results at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN1(positive)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN1(negative)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN2 (positive)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN2 (negative)', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN3 (positive)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN3 (negative)', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 (positive)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2(negative)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN3(positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}, {'title': 'CIN2 and CIN3 (positive)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CIN2 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 and CIN3 (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}, {'title': 'AIS (positive)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AIS (negative)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}]}]}, {'title': 'Invasive malignancy (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Invasive malignancy (negative)', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 24', 'description': 'Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.\n\nCIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.\n\nNote: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Cervical Biopsy Results at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN1(positive)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN1(negative)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN2 (positive)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN2 (negative)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN3 (positive)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN3 (negative)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2(negative)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN3(positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'CIN2 and CIN3 (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN2 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 and CIN3 (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'AIS (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AIS (negative)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Invasive malignancy (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Invasive malignancy (negative)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 36', 'description': 'Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.\n\nCIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.\n\nNote: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Cervical Biopsy Results at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN1(positive)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN1(negative)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN2 (positive)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN2 (negative)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN3 (positive)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Only CIN3 (negative)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 (positive)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2(negative)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN3(positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'CIN2 and CIN3 (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN2 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 and CIN3 (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CIN1 and CIN2 and CIN3 (negative)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'AIS (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AIS (negative)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Invasive malignancy (positive)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Invasive malignancy (negative)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 48', 'description': 'Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.\n\nCIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.\n\nNote: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Referrals by Treatment Type at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Treatment referral, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Treatment referral, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '359', 'groupId': 'OG000'}]}]}, {'title': 'Loop excision of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Loop excision of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Loop cone of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Loop cone of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Cold knife cone of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cold knife cone of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Laser excision, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Laser excision, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 12', 'description': "If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.\n\nThe treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Referrals by Treatment Type at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Treatment referral, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Treatment referral, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}]}]}, {'title': 'Treatment referral, Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Loop excision of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Loop excision of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Loop cone of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Loop cone of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Cold knife cone of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cold knife cone of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Laser excision, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Laser excision, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 24', 'description': "If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.\n\nThe treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Referrals by Treatment Type at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Treatment referral, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Treatment referral, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}, {'title': 'Loop excision of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Loop excision of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Loop cone of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Loop cone of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Cold knife cone of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cold knife cone of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Laser excision, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Laser excision, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 36', 'description': "If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.\n\nThe treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Referrals by Treatment Type at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Treatment referral, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Treatment referral, No \\', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Loop excision of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Loop excision of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Loop cone of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Loop cone of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Cold knife cone of cervix, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cold knife cone of cervix, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Laser excision, Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Laser excision, No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 48', 'description': "If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.\n\nThe treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects for whom data were available at the considered time point and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects who had their symptom sheet completed and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'classes': [{'title': 'Subjects with fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with any related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Subjects with any SAEs due to concurrent GSK medic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Total HPV-052 cohort, which included subjects who had their symptom sheet completed and who at their last HPV-008 (NCT00122681) study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant so that no cervical sample could be collected at that visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2003'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1787'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '144'}]}, {'type': 'Missing confirmed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}]}], 'preAssignmentDetails': 'Out of the 2022 subjects enrolled in this study, 19 were excluded for reasons of non-eligibility, hence only 2003 started the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2003', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HPV-052 Study Subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '3.06', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2003', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'White/Caucasian', 'measurements': [{'value': '1211', 'groupId': 'BG000'}]}, {'title': 'Arabic/north African', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'East & south east Asian', 'measurements': [{'value': '549', 'groupId': 'BG000'}]}, {'title': 'South Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Chinese', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Indian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not specified', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2022}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2014-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2009-07-02', 'resultsFirstSubmitDate': '2015-01-08', 'studyFirstSubmitQcDate': '2009-07-09', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-08', 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)', 'timeFrame': 'At Months 12, 24, 36, 48', 'description': 'Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68.\n\nMissing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).'}, {'measure': 'Number of Subjects With Colposcopy Referral and Colposcopy Adequacy', 'timeFrame': 'At Months 12, 24, 36, 48', 'description': "Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects' last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of ≥ atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of ≥ low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result."}, {'measure': 'Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest', 'timeFrame': 'At Months 12, 24, 36, 48', 'description': 'Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.\n\nCervical cytology examination was performed using the ThinPrep PapTest. Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis.'}, {'measure': 'Number of Subjects With Cervical Biopsy Results at Month 12', 'timeFrame': 'At Month 12', 'description': 'Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.\n\nCIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.\n\nNote: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.'}, {'measure': 'Number of Subjects With Cervical Biopsy Results at Month 24', 'timeFrame': 'At Month 24', 'description': 'Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.\n\nCIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.\n\nNote: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.'}, {'measure': 'Number of Subjects With Cervical Biopsy Results at Month 36', 'timeFrame': 'At Month 36', 'description': 'Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.\n\nCIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.\n\nNote: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.'}, {'measure': 'Number of Subjects With Cervical Biopsy Results at Month 48', 'timeFrame': 'At Month 48', 'description': 'Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.\n\nCIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.\n\nNote: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.'}, {'measure': 'Number of Subjects With Treatment Referrals by Treatment Type at Month 12', 'timeFrame': 'At Month 12', 'description': "If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.\n\nThe treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other."}, {'measure': 'Number of Subjects With Treatment Referrals by Treatment Type at Month 24', 'timeFrame': 'At Month 24', 'description': "If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.\n\nThe treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other."}, {'measure': 'Number of Subjects With Treatment Referrals by Treatment Type at Month 36', 'timeFrame': 'At Month 36', 'description': "If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.\n\nThe treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other."}, {'measure': 'Number of Subjects With Treatment Referrals by Treatment Type at Month 48', 'timeFrame': 'At Month 48', 'description': "If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject's participation in the study concluded after treatment.\n\nThe treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other."}, {'measure': 'Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal', 'timeFrame': 'From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.', 'timeFrame': 'From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]', 'description': 'SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.'}]}, 'conditionsModule': {'keywords': ['HPV', 'Papillomavirus', 'Human papillomavirus', 'Cervical cancer', 'HPV vaccine'], 'conditions': ['Infections, Papillomavirus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudydatarequest.com', 'label': 'IPD for this study will be made available via the Clinical Study Data Request site.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study visit (Visit 10, Month 48).\n\nThis follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit.\n\nThe objectives \\& outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent obtained from the subject prior to enrolment.\n* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.\n* A subject previously enrolled in the study NCT00122681 and who fulfils either of the following criteria:\n\n * displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).\n\nor\n\n\\- was pregnant at her last visit of the NCT00122681 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.\n\nExclusion Criteria:\n\n* A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).\n* A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit colposcopy.\n* A subject for whom the cervical cytology results from the last NCT00122681 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.\n\nIf at the time of enrolment the subject experiences heavy bleeding (menstruation or other) or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The subject's first study visit will be deferred until condition is resolved according to investigator's medical judgment."}, 'identificationModule': {'nctId': 'NCT00937950', 'briefTitle': 'Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Gynaecological Follow-up of a Subset of 580299/008 Study Subjects', 'orgStudyIdInfo': {'id': '112024'}, 'secondaryIdInfos': [{'id': '2008-008124-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HPV-052 study subjects Group', 'description': 'The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit.', 'interventionNames': ['Other: Gynaecological follow-up']}], 'interventions': [{'name': 'Gynaecological follow-up', 'type': 'OTHER', 'description': 'Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.', 'armGroupLabels': ['HPV-052 study subjects Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '67207', 'city': 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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. 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