Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT00337818
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Finland']}, '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': 'C510352', 'term': 'human papillomavirus vaccine, L1 type 16, 18'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': 'During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.', 'description': 'Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.\n\nThe number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 186, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the old manufacturing process.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Cervarix Young', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blighted ovum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chorioamnionitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stillbirth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature separation of placenta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}, {'id': 'OG001', 'title': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the old manufacturing process.'}, {'id': 'OG002', 'title': 'Cervarix Young', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}], 'classes': [{'title': 'Anti-HPV-16 (Month 24) (n=160, 51, 55)', 'categories': [{'measurements': [{'value': '1440.4', 'groupId': 'OG000', 'lowerLimit': '1249.3', 'upperLimit': '1660.7'}, {'value': '1903.7', 'groupId': 'OG001', 'lowerLimit': '1396.0', 'upperLimit': '2596.0'}, {'value': '3861.7', 'groupId': 'OG002', 'lowerLimit': '2947.0', 'upperLimit': '5060.4'}]}]}, {'title': 'Anti-HPV-16 (Month 36) (n=150, 46, 52)', 'categories': [{'measurements': [{'value': '1397.5', 'groupId': 'OG000', 'lowerLimit': '1207.1', 'upperLimit': '1618.1'}, {'value': '1679.3', 'groupId': 'OG001', 'lowerLimit': '1211.5', 'upperLimit': '2327.6'}, {'value': '3353.0', 'groupId': 'OG002', 'lowerLimit': '2553.4', 'upperLimit': '4403.1'}]}]}, {'title': 'Anti-HPV-16 (Month 48) (n=141, 49, 49)', 'categories': [{'measurements': [{'value': '1140.9', 'groupId': 'OG000', 'lowerLimit': '974.9', 'upperLimit': '1335.3'}, {'value': '1427.3', 'groupId': 'OG001', 'lowerLimit': '1027.6', 'upperLimit': '1982.4'}, {'value': '2862.2', 'groupId': 'OG002', 'lowerLimit': '2129.3', 'upperLimit': '3847.3'}]}]}, {'title': 'Anti-HPV-18 (Month 24) (n=160, 50, 54)', 'categories': [{'measurements': [{'value': '649.8', 'groupId': 'OG000', 'lowerLimit': '554.3', 'upperLimit': '761.8'}, {'value': '778.8', 'groupId': 'OG001', 'lowerLimit': '577.1', 'upperLimit': '1050.8'}, {'value': '1341.8', 'groupId': 'OG002', 'lowerLimit': '1053.2', 'upperLimit': '1709.6'}]}]}, {'title': 'Anti-HPV-18 (Month 36) (n=151, 45, 51)', 'categories': [{'measurements': [{'value': '574.7', 'groupId': 'OG000', 'lowerLimit': '490.2', 'upperLimit': '673.7'}, {'value': '649.6', 'groupId': 'OG001', 'lowerLimit': '464.5', 'upperLimit': '908.4'}, {'value': '1111.0', 'groupId': 'OG002', 'lowerLimit': '848.5', 'upperLimit': '1454.9'}]}]}, {'title': 'Anti-HPV-18 (Month 48) (n=141, 48, 48)', 'categories': [{'measurements': [{'value': '462.4', 'groupId': 'OG000', 'lowerLimit': '391.5', 'upperLimit': '546.1'}, {'value': '519.9', 'groupId': 'OG001', 'lowerLimit': '374.1', 'upperLimit': '722.4'}, {'value': '935.6', 'groupId': 'OG002', 'lowerLimit': '717.9', 'upperLimit': '1219.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At months 18*, 24, 36 and 48', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).\n\n\\*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.'}, {'type': 'SECONDARY', 'title': 'Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}, {'id': 'OG001', 'title': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the old manufacturing process.'}, {'id': 'OG002', 'title': 'Cervarix Young', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}], 'classes': [{'title': 'HPV-16 (Month 24) (n= 55, 13, 1)', 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '57.9', 'upperLimit': '125.8'}, {'value': '107.5', 'groupId': 'OG001', 'lowerLimit': '47.5', 'upperLimit': '242.8'}, {'value': '198.8', 'groupId': 'OG002', 'lowerLimit': '198.8', 'upperLimit': '198.8'}]}]}, {'title': 'HPV-16 (Month 36) (n= 78, 27, 3)', 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000', 'lowerLimit': '54.6', 'upperLimit': '85.2'}, {'value': '62.1', 'groupId': 'OG001', 'lowerLimit': '40.8', 'upperLimit': '94.7'}, {'value': '63.4', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '845.9'}]}]}, {'title': 'HPV-16 (Month 48) (n=69, 19, 4)', 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '43.4', 'upperLimit': '72.8'}, {'value': '94.5', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '175.8'}, {'value': '129.2', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '1305.0'}]}]}, {'title': 'HPV-18 (Month 24) (n= 55, 13, 1)', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '67.6'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '64.4'}, {'value': '107.9', 'groupId': 'OG002', 'lowerLimit': '107.9', 'upperLimit': '107.9'}]}]}, {'title': 'HPV-18 (Month 36) (n= 78, 27, 3)', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '48.6'}, {'value': '29.6', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '44.2'}, {'value': '19.9', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '362.2'}]}]}, {'title': 'HPV-18 (Month 48) (n= 66, 19, 4)', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '46.5'}, {'value': '48.8', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '90.0'}, {'value': '97.5', 'groupId': 'OG002', 'lowerLimit': '38.7', 'upperLimit': '245.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At months 24, 36, and 48', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.'}, {'type': 'SECONDARY', 'title': 'Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}, {'id': 'OG001', 'title': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the old manufacturing process.'}, {'id': 'OG002', 'title': 'Cervarix Young', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}], 'classes': [{'title': 'Anti-HPV-16 [Month 24] (n=74;24;3)', 'categories': [{'measurements': [{'value': '1403.1', 'groupId': 'OG000', 'lowerLimit': '1126.9', 'upperLimit': '1747.0'}, {'value': '1490.5', 'groupId': 'OG001', 'lowerLimit': '1016.1', 'upperLimit': '2186.5'}, {'value': '5399.5', 'groupId': 'OG002', 'lowerLimit': '367.9', 'upperLimit': '79243.9'}]}]}, {'title': 'Anti-HPV-16 [Month 36] (n=78;27;3)', 'categories': [{'measurements': [{'value': '1291.8', 'groupId': 'OG000', 'lowerLimit': '1030.9', 'upperLimit': '1618.7'}, {'value': '1435.0', 'groupId': 'OG001', 'lowerLimit': '993.0', 'upperLimit': '2073.8'}, {'value': '3733.3', 'groupId': 'OG002', 'lowerLimit': '383.1', 'upperLimit': '36384.7'}]}]}, {'title': 'Anti-HPV-16 [Month 48] (n=69;19;4)', 'categories': [{'measurements': [{'value': '1047.3', 'groupId': 'OG000', 'lowerLimit': '854.2', 'upperLimit': '1284.0'}, {'value': '1950.5', 'groupId': 'OG001', 'lowerLimit': '1095.1', 'upperLimit': '3474.1'}, {'value': '3332.7', 'groupId': 'OG002', 'lowerLimit': '1087.6', 'upperLimit': '10212.5'}]}]}, {'title': 'Anti-HPV-18 [Month 24] (n=74;24;3)', 'categories': [{'measurements': [{'value': '584.5', 'groupId': 'OG000', 'lowerLimit': '461.1', 'upperLimit': '741.0'}, {'value': '648.6', 'groupId': 'OG001', 'lowerLimit': '467.7', 'upperLimit': '899.6'}, {'value': '1814.6', 'groupId': 'OG002', 'lowerLimit': '240.3', 'upperLimit': '13702.9'}]}]}, {'title': 'Anti-HPV-18 [Month 36] (n=78;27;3)', 'categories': [{'measurements': [{'value': '555.4', 'groupId': 'OG000', 'lowerLimit': '439.3', 'upperLimit': '702.1'}, {'value': '542.1', 'groupId': 'OG001', 'lowerLimit': '392.8', 'upperLimit': '748.0'}, {'value': '1163.6', 'groupId': 'OG002', 'lowerLimit': '88.8', 'upperLimit': '15244.0'}]}]}, {'title': 'Anti-HPV-18 [Month 48] (n=66;19;4)', 'categories': [{'measurements': [{'value': '478.4', 'groupId': 'OG000', 'lowerLimit': '376.8', 'upperLimit': '607.3'}, {'value': '805.4', 'groupId': 'OG001', 'lowerLimit': '491.2', 'upperLimit': '1320.5'}, {'value': '1048.9', 'groupId': 'OG002', 'lowerLimit': '250.5', 'upperLimit': '4392.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 24, 36 and 48', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}, {'id': 'OG001', 'title': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the old manufacturing process.'}, {'id': 'OG002', 'title': 'Cervarix Young', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}], 'classes': [{'title': 'NOCDs from Month 12 to Month 24 (n= 186, 64, 57)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NOCDs from Month 24 to Month 36 (n= 184, 65, 53)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NOCDs from Month 36 to Month 48 (n= 169, 63, 51)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'MSCs from Month 12 to Month 24 (n= 186, 64, 57)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'MSCs from Month 24 to Month 36 (n= 184, 65, 53)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'MSCs from Month 36 to Month 48 (n= 169, 63, 51)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pregnancies from Month 12 to Month 24(n=186,64,57)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pregnancies from Month 24 to Month 36(n=184,65,53)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pregnancies from Month 36 to Month 48(n=169,63,51)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (up to Month 48)', 'description': 'NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}, {'id': 'OG001', 'title': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the old manufacturing process.'}, {'id': 'OG002', 'title': 'Cervarix Young', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}], 'classes': [{'title': 'From Month 12 to 24 (n=186,64,57)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'From Month 24 to 36 (n=184,65,53)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'From Month 36 to 48 (n=169,63,51)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (up to Month 48)', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total vaccinated cohort of each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}, {'id': 'FG001', 'title': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the old manufacturing process.'}, {'id': 'FG002', 'title': 'Cervarix Young', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '158'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '107'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '107'}]}]}], 'preAssignmentDetails': 'Only 8 subjects came to Month 18 whereas most of the subjects came to Month 24. Therefore, no separate analysis at Month 18 was prepared; data for Month 18 outcome variables were incorporated into Month 24 analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '770', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}, {'id': 'BG001', 'title': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the old manufacturing process.'}, {'id': 'BG002', 'title': 'Cervarix Young', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\] vaccine) produced with the new manufacturing process.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '2.96', 'groupId': 'BG000'}, {'value': '20.3', 'spread': '2.99', 'groupId': 'BG001'}, {'value': '12.4', 'spread': '1.37', 'groupId': 'BG002'}, {'value': '18.6', 'spread': '4.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '458', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '770', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 770}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2006-06-15', 'resultsFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2006-06-15', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-02-12', 'studyFirstPostDateStruct': {'date': '2006-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies', 'timeFrame': 'At months 18*, 24, 36 and 48', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).\n\n\\*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.'}], 'secondaryOutcomes': [{'measure': 'Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples', 'timeFrame': 'At months 24, 36, and 48', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.'}, {'measure': 'Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples', 'timeFrame': 'At Months 24, 36 and 48', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.'}, {'measure': 'Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)', 'timeFrame': 'Throughout the study period (up to Month 48)', 'description': 'NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.'}, {'measure': 'Number of Subjects Reporting SAEs', 'timeFrame': 'Throughout the study period (up to Month 48)', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.'}]}, 'conditionsModule': {'keywords': ['Non-inferiority', 'Immunogenicity', 'HPV Vaccine Consistency'], 'conditions': ['Papillomavirus Type 16/18 Infection', 'Cervical Intraepithelial Neoplasia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrials.gov/ct/show/NCT00169494', 'label': 'Primary Study'}]}, 'descriptionModule': {'briefSummary': 'The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.', 'detailedDescription': 'Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).\n* Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).\n\nExclusion criteria\n\n* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.\n* Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.'}, 'identificationModule': {'nctId': 'NCT00337818', 'briefTitle': 'Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women', 'nctIdAliases': ['NCT00337844', 'NCT00337857', 'NCT00338169'], 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "A Long-term, Open, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1/AS04 Vaccine in Healthy Female Subjects Vaccinated Either Pre- or Post-menarche in the Primary Study", 'orgStudyIdInfo': {'id': '107476 (M18)'}, 'secondaryIdInfos': [{'id': '107477', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '107479', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '107481', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervarix New Process', 'description': 'Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\]) produced with the new manufacturing process.', 'interventionNames': ['Biological: Cervarix™']}, {'type': 'EXPERIMENTAL', 'label': 'Cervarix Old Process Group', 'description': 'Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\]) produced with the old manufacturing process.', 'interventionNames': ['Biological: Cervarix™']}, {'type': 'EXPERIMENTAL', 'label': 'Cervarix Young/Lot 1 Group', 'description': 'Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus \\[HPV\\]) produced with the new manufacturing process (Lot 1).', 'interventionNames': ['Biological: Cervarix™']}], 'interventions': [{'name': 'Cervarix™', 'type': 'BIOLOGICAL', 'description': 'Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)', 'armGroupLabels': ['Cervarix New Process', 'Cervarix Old Process Group', 'Cervarix Young/Lot 1 Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1162', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}