Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-03 @ 3:08 AM
Study NCT ID:
NCT00637195
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2008-02-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'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': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510352', 'term': 'human papillomavirus vaccine, L1 type 16, 18'}, {'id': 'C075654', 'term': 'Engerix-B'}]}}, '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': 'From Month 0 up to Month 13.', 'eventGroups': [{'id': 'EG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12).", 'otherNumAtRisk': 76, 'otherNumAffected': 76, 'seriousNumAtRisk': 76, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).', 'otherNumAtRisk': 76, 'otherNumAffected': 73, 'seriousNumAtRisk': 76, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pain at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Redness at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Swelling at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Abortion spontaneous complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': "Graves-Basedow's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 3', 'description': 'A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination .'}, {'type': 'PRIMARY', 'title': 'Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'categories': [{'measurements': [{'value': '156.1', 'groupId': 'OG000', 'lowerLimit': '83.7', 'upperLimit': '291.3'}, {'value': '146.2', 'groupId': 'OG001', 'lowerLimit': '86.6', 'upperLimit': '246.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 3', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'title': 'Anti-HPV-16, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Anti-HPV-16, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Anti-HPV-18, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Anti-HPV-18, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 2 and 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 subject seronegative before vaccination.\n\nCut-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 the According-to-Protocol (ATP) cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine and with available data.'}, {'type': 'SECONDARY', 'title': 'Anti-HPV-16/18 Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'title': 'Anti-HPV-16, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3497.2', 'groupId': 'OG000', 'lowerLimit': '2902.3', 'upperLimit': '4214.1'}]}]}, {'title': 'Anti-HPV-16, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8725.2', 'groupId': 'OG000', 'lowerLimit': '7105.7', 'upperLimit': '10714.0'}]}]}, {'title': 'Anti-HPV-18, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2775.6', 'groupId': 'OG000', 'lowerLimit': '2306.5', 'upperLimit': '3340.1'}]}]}, {'title': 'Anti-HPV-18, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4664.4', 'groupId': 'OG000', 'lowerLimit': '3709.9', 'upperLimit': '5864.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Months 2 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 ATP cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 2, 3 and 13', 'description': 'Anti-HBs seroconversion is defined as the appearance \\[i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)\\] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 2 and 13', 'description': 'A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.'}, {'type': 'SECONDARY', 'title': 'Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '69.5'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '67.1'}]}]}, {'title': 'Month 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19888.4', 'groupId': 'OG000', 'lowerLimit': '13042.6', 'upperLimit': '30327.5'}, {'value': '16927.5', 'groupId': 'OG001', 'lowerLimit': '11854.1', 'upperLimit': '24172.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 2 and 13', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B 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'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day period following the 4th dose of HBV vaccine', 'description': 'Solicited local symptoms assessed include injection site pain, redness and swelling.\n\nData are presented across doses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 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'Urticaria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day period following any vaccination', 'description': 'Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \\[axillary route, ≥ 37.5 degree Celsius (°C)\\] and urticaria.\n\nData are presented across doses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Gastro-intestinal symptoms', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Temperature ≥ 37.5°C', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day period following the 4th dose of HBV vaccine', 'description': 'Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \\[axillary route, ≥ 37.5 degree Celsius (°C)\\] and urticaria.\n\nData are presented across doses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-day period following any vaccination', 'description': 'Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with 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'22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-day period following the 4th dose of HBV vaccine', 'description': 'Unsolicited adverse event covers any adverse event 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'OG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to study end (Month 13)', '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': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Medically Significant 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that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'FG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12)."}, {'id': 'BG001', 'title': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'spread': '1.51', 'groupId': 'BG000'}, {'value': '22.1', 'spread': '1.32', 'groupId': 'BG001'}, {'value': '22.3', 'spread': '1.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '152', '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2009-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-31', 'studyFirstSubmitDate': '2008-02-28', 'resultsFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2008-03-10', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-11-12', 'studyFirstPostDateStruct': {'date': '2008-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix', 'timeFrame': 'Month 3', 'description': 'A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).'}, {'measure': 'Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix', 'timeFrame': 'Month 3', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies', 'timeFrame': 'Months 2 and 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 subject seronegative before vaccination.\n\nCut-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.'}, {'measure': 'Anti-HPV-16/18 Antibody Titers', 'timeFrame': 'Months 2 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 Seroconverted for Anti-hepatitis B (HBs) Antibodies', 'timeFrame': 'Months 2, 3 and 13', 'description': 'Anti-HBs seroconversion is defined as the appearance \\[i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)\\] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.'}, {'measure': 'Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course', 'timeFrame': 'Months 2 and 13', 'description': 'A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.'}, {'measure': 'Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course', 'timeFrame': 'At Months 2 and 13', 'description': 'Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.'}, {'measure': 'Number of Subjects Reporting Solicited Local Symptoms', 'timeFrame': 'During the 7-day period following any vaccination', 'description': 'Solicited local symptoms assessed include injection site pain, redness and swelling.\n\nData are presented across doses.'}, {'measure': 'Number of Subjects Reporting Solicited Local Symptoms', 'timeFrame': 'During the 7-day period following the 4th dose of HBV vaccine', 'description': 'Solicited local symptoms assessed include injection site pain, redness and swelling.\n\nData are presented across doses.'}, {'measure': 'Number of Subjects Reporting Solicited General Symptoms', 'timeFrame': 'During the 7-day period following any vaccination', 'description': 'Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \\[axillary route, ≥ 37.5 degree Celsius (°C)\\] and urticaria.\n\nData are presented across doses.'}, {'measure': 'Number of Subjects Reporting Solicited General Symptoms', 'timeFrame': 'During the 7-day period following the 4th dose of HBV vaccine', 'description': 'Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature \\[axillary route, ≥ 37.5 degree Celsius (°C)\\] and urticaria.\n\nData are presented across doses.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events', 'timeFrame': 'During the 30-day period following any vaccination', 'description': 'Unsolicited adverse event covers any adverse event 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.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events', 'timeFrame': 'During the 30-day period following the 4th dose of HBV vaccine', 'description': 'Unsolicited adverse event covers any adverse event 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.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAE)', 'timeFrame': 'Up to study end (Month 13)', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or 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Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.'}]}, 'conditionsModule': {'keywords': ['Human papillomavirus (HPV) vaccine', 'Hepatitis B', 'Cervical cancer', 'HPV', 'Papillomavirus'], 'conditions': ['Infections, Papillomavirus', 'Papillomavirus Vaccines']}, 'referencesModule': {'availIpds': [{'id': '111567', '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': '111567', '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': '111567', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111567', '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': '111567', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111567', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111567', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '21734063', 'type': 'BACKGROUND', 'citation': 'Leroux-Roels G, Haelterman E, Maes C, Levy J, De Boever F, Licini L, David MP, Dobbelaere K, Descamps D. Randomized trial of the immunogenicity and safety of the Hepatitis B vaccine given in an accelerated schedule coadministered with the human papillomavirus type 16/18 AS04-adjuvanted cervical cancer vaccine. Clin Vaccine Immunol. 2011 Sep;18(9):1510-8. doi: 10.1128/CVI.00539-10. Epub 2011 Jul 6.'}, {'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': "Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals' HPV vaccine GSK580299 in healthy female subjects."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\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, 20 and 25 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 history directed clinical examination before entering into the study.\n* Subjects must not be pregnant.\n* Subjects must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.\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 before and 30 days after each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed.\n* Concurrently participating in another clinical study, at any time during the study period (up to Month 13), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.\n* Pregnant or breastfeeding women.\n* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period\n* Previous administration of components of the investigational vaccine.\n* Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.\n* History of hepatitis B infection.\n* Known exposure to hepatitis B within the previous 6 weeks.\n* Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.\n* Cancer or autoimmune disease under treatment.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination\n* Acute disease at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.'}, 'identificationModule': {'nctId': 'NCT00637195', 'briefTitle': 'Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Evaluation of the Immunogenicity and Safety of a Commercially Available Vaccine When Co-administered With GlaxoSmithKline Biologicals' HPV Vaccine (580299) in Healthy Female Subjects.", 'orgStudyIdInfo': {'id': '111567'}, 'secondaryIdInfos': [{'id': '2007-007876-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervarix™ & Engerix™ Group', 'description': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \\& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \\& 12).", 'interventionNames': ["Biological: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™)", 'Biological: Engerix™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Engerix™ Group', 'description': 'Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \\& 12).', 'interventionNames': ['Biological: Engerix™']}], 'interventions': [{'name': "Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™)", 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' HPV vaccine 580299"], 'description': 'Intramuscular administration, 3 doses.', 'armGroupLabels': ['Cervarix™ & Engerix™ Group']}, {'name': 'Engerix™', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' vaccine 103860"], 'description': 'Intramuscular administration, 4 doses.', 'armGroupLabels': ['Cervarix™ & Engerix™ Group', 'Engerix™ Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=211', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}