Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT00344032
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2006-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], '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'}]}, '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': {'description': 'Events collected by systematic assessment are reported for subjects with a symptom diary card available.\n\nEvents collected by non-systematic method are reported for the Total Vaccinated Cohort', 'eventGroups': [{'id': 'EG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).', 'otherNumAtRisk': 176, 'otherNumAffected': 153, 'seriousNumAtRisk': 176, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).', 'otherNumAtRisk': 178, 'otherNumAffected': 132, 'seriousNumAtRisk': 178, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 105}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever (above 37.5 degree Celsius)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastro-intestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 71}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Aborption spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchogenic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymph node tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).'}], 'classes': [{'title': 'Anti-HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Anti-HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 7', 'description': 'Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity.'}, {'type': 'SECONDARY', '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': '148', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).'}], 'classes': [{'title': 'Anti-HPV-16 (Month 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '6.1'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '5.5'}]}]}, {'title': 'Anti-HPV-16 (Month 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9813.8', 'groupId': 'OG000', 'lowerLimit': '8605.4', 'upperLimit': '11191.9'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '7.0'}]}]}, {'title': 'Anti-HPV-18 (Month 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '5.2'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.1'}]}]}, {'title': 'Anti-HPV-18 (Month 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4030.1', 'groupId': 'OG000', 'lowerLimit': '3544.0', 'upperLimit': '4582.8'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '5.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 0 and 7', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).', '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Fever (above 37.5 degree Celsius)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Gastro-intestinal symptoms', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7 days (Days 0 - 6) after each vaccination', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days (Days 0 - 29) after each vaccination', 'description': 'Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).'}], 'classes': [{'title': 'NOCDs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Medically Significant AEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study period (up to Month 7)', 'description': 'NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study period (up to Month 7)', 'description': 'Serious adverse events assessed include medical occurrences that results in death, is 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': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'spread': '4.70', 'groupId': 'BG000'}, {'value': '28.5', 'spread': '4.97', 'groupId': 'BG001'}, {'value': '28.5', 'spread': '4.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 354}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07-28'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2006-06-23', 'resultsFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2006-06-23', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-11-12', 'studyFirstPostDateStruct': {'date': '2006-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies', 'timeFrame': 'At Month 7', 'description': 'Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.'}], 'secondaryOutcomes': [{'measure': 'Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies', 'timeFrame': 'At Months 0 and 7', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).'}, {'measure': 'Number of Subjects Reporting Solicited Symptoms', 'timeFrame': 'During the 7 days (Days 0 - 6) after each vaccination', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 30 days (Days 0 - 29) after each vaccination', 'description': 'Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)', 'timeFrame': 'Throughout the study period (up to Month 7)', 'description': 'NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events', 'timeFrame': 'Throughout the study period (up to Month 7)', 'description': 'Serious adverse events assessed include medical occurrences that results in death, is 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': ['Double-blind', 'Human Papillomavirus', 'Phase IIIb', 'Controlled', 'Randomized', 'India'], 'conditions': ['Infections, Papillomavirus']}, 'referencesModule': {'availIpds': [{'id': '104479', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104479', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104479', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104479', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104479', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104479', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '20178538', 'type': 'BACKGROUND', 'citation': 'Bhatla N, Suri V, Basu P, Shastri S, Datta SK, Bi D, Descamps DJ, Bock HL; Indian HPV Vaccine Study Group. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women. J Obstet Gynaecol Res. 2010 Feb;36(1):123-32. doi: 10.1111/j.1447-0756.2009.01167.x.'}, {'pmid': '18845199', 'type': 'BACKGROUND', 'citation': 'Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.'}, {'pmid': '41276263', 'type': 'DERIVED', 'citation': 'Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1/AS04 vaccine and the safety of the vaccine.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects must satisfy the following criteria at study entry:\n\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 female between, and including, 18 and 35 years of age at the time of the first vaccination.\n* Written informed consent obtained from the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Subjects must have a negative urine pregnancy test.\n* Subjects of childbearing potential at the time of study entry must be abstinent or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.\n\nExclusion Criteria:\n\nThe following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/ control within 30 days preceding the first dose of study vaccine/ control, or planned use during the study period.\n* Pregnant or breastfeeding.\n* Planning to become pregnant or likely to become pregnant.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.\n* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days (Days 1 to 30) before and 30 days (Day 0- Day 29) after the first dose of vaccine. Administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before the first dose of study vaccine is allowed.\n* Previous administration of components of the investigational vaccine.\n* Previous vaccination against HPV.\n* Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.\n* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.\n* Hypersensitivity to latex.\n* Known acute or chronic, clinically significant neurologic, hepatic or renal functional pulmonary, cardiovascular abnormality, as determined by previous physical examination or laboratory tests.\n* History of chronic condition(s) requiring treatment.\n* Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine/ control or planned administration during the study period. Enrolment will be deferred until condition is resolved.\n* Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever.'}, 'identificationModule': {'nctId': 'NCT00344032', 'briefTitle': "Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV-16/18 VLP/AS04 Vaccine Administered Intramuscularly at 0, 1, 6 Months in Healthy Indian Female Subjects Aged 18-35 Yrs", 'orgStudyIdInfo': {'id': '104479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervarix', 'description': 'Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).', 'interventionNames': ['Biological: HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects who received 3 doses of Placebo (at 0, 1, 6 months).', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.', 'armGroupLabels': ['Placebo']}, {'name': 'HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' HPV-16/18 VLP/AS04 vaccine"], 'description': 'Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.', 'armGroupLabels': ['Cervarix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'zip': '700026', 'city': 'Kolkata', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '400 012', 'city': 'Mumbai', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '110029', 'city': 'New Delhi', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}