Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT00316693
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2006-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine
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': {'timeFrame': '- For serious adverse events: thoughout the study period (up to Month 24). - For other adverse events: -- during the 30-day (non-systematically assessed) or -- during the 7-day (systematically assessed) follow-up period after any vaccination.', 'description': 'Total number of subjects at risk corresponds to\n\n* all subjects in the Total Vaccinated Cohort for serious events and non-systematically assessed other events;\n* those subjects in the Total Vaccinated Cohort with at least one documented dose.', 'eventGroups': [{'id': 'EG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.', 'otherNumAtRisk': 519, 'deathsNumAtRisk': 519, 'otherNumAffected': 512, 'seriousNumAtRisk': 519, 'deathsNumAffected': 1, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.', 'otherNumAtRisk': 521, 'deathsNumAtRisk': 521, 'otherNumAffected': 459, 'seriousNumAtRisk': 521, 'deathsNumAffected': 0, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 508}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 214}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 455}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 287}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 401}, {'groupId': 'EG001', 'numAtRisk': 510, 'numAffected': 165}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 341}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 300}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 167}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 250}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 222}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 262}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 128}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 512, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 91}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abortion threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Threatened labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abortion spontaneous incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergic granulomatous angiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Avulsion fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Borderline personality disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eyeball rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Mastitis postpartum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Moyamoya disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ovarian haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Panic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Polycystic ovaries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 519, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 521, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study period (up to Month 24)', 'description': 'Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (\\> 150 days) \\[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 24', 'description': 'HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 24', 'description': 'Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 24', 'description': 'Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Any HR HPV types except HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Any HR HPV types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 24', 'description': 'Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6.\n\nOncogenic (high risk \\[HR\\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any HR HPV types except HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Any HR HPV types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 24', 'description': 'Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (\\> 150 days) \\[as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6\\].\n\nOncogenic (high risk \\[HR\\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any HR HPV types except HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Any HR HPV types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 24', 'description': 'Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6.\n\nOncogenic (high risk \\[HR\\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any HR HPV types except HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Any HR HPV types', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 24', 'description': 'Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6.\n\nOncogenic (high risk \\[HR\\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16 (pre-vaccination)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '411', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 (Month 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '410', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '373', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '356', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 (pre-vaccination)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '410', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 (Month 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24', 'description': 'Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for 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': '411', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Anti-HPV-16 (Month 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '5.9'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '5.7'}]}]}, {'title': 'Anti-HPV-16 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '708.4', 'groupId': 'OG000', 'lowerLimit': '650.1', 'upperLimit': '772.0'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '5.8'}]}]}, {'title': 'Anti-HPV-16 (Month 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7441.0', 'groupId': 'OG000', 'lowerLimit': '6854.3', 'upperLimit': '8077.8'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '5.8'}]}]}, {'title': 'Anti-HPV-16 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2877.7', 'groupId': 'OG000', 'lowerLimit': '2623.1', 'upperLimit': '3156.9'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '5.8'}]}]}, {'title': 'Anti-HPV-16 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1864.8', 'groupId': 'OG000', 'lowerLimit': '1694.5', 'upperLimit': '2052.2'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '5.8'}]}]}, {'title': 'Anti-HPV-16 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1532.2', 'groupId': 'OG000', 'lowerLimit': '1395.1', 'upperLimit': '1682.7'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '5.9'}]}]}, {'title': 'Anti-HPV-18 (Month 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '4.8'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '4.7'}]}]}, {'title': 'Anti-HPV-18 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '504.6', 'groupId': 'OG000', 'lowerLimit': '464.6', 'upperLimit': '548.1'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '4.7'}]}]}, {'title': 'Anti-HPV-18 (Month 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3805.4', 'groupId': 'OG000', 'lowerLimit': '3515.6', 'upperLimit': '4119.1'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '4.8'}]}]}, {'title': 'Anti-HPV-18 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1330.7', 'groupId': 'OG000', 'lowerLimit': '1210.2', 'upperLimit': '1463.2'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '4.8'}]}]}, {'title': 'Anti-HPV-18 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '782.0', 'groupId': 'OG000', 'lowerLimit': '703.4', 'upperLimit': '869.5'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '4.7'}]}]}, {'title': 'Anti-HPV-18 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '627.8', 'groupId': 'OG000', 'lowerLimit': '566.3', 'upperLimit': '696.0'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '4.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 0, 6, 7, 12, 18 and 24', '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 immunogenicity.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local and General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '508', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '455', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '341', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Gastro-intestinal symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after each and any vaccination', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal 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 (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '294', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days after any vaccination', 'description': 'Unsolicited AE covers any AE 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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study period (up to Month 24)', '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.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'NOCDs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'MSCs', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study period (up to Month 24)', 'description': 'NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) 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.'}, {'type': 'SECONDARY', 'title': 'Outcome of Any Reported Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Normal infant', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Premature birth', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Spontaneous abortion', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lost to follow-up', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy ongoing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study period (up to Month 24)', 'description': 'Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on those subjects reporting pregnancy during the study period.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Hemoglobin Normal [Month 0]', 'categories': [{'measurements': [{'value': '499', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Above [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Below [Month 0]', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Unknown [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Normal [Month 7]', 'categories': [{'measurements': [{'value': '448', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Above [Month 7]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Below [Month 7]', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Normal [Month 0]', 'categories': [{'measurements': [{'value': '501', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Above [Month 0]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Below [Month 0]', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Unknown [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Normal [Month 7]', 'categories': [{'measurements': [{'value': '448', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Above [Month 7]', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Below [Month 7]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count Normal [Month 0]', 'categories': [{'measurements': [{'value': '504', 'groupId': 'OG000'}, {'value': '514', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count Above [Month 0]', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count Unknown [Month 0]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count Normal [Month 7]', 'categories': [{'measurements': [{'value': '456', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count Above [Month 7]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count Below [Month 7]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count Unknown [Month 7]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Red Blood Cells count Normal [Month 0]', 'categories': [{'measurements': [{'value': '514', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}]}, {'title': 'Red Blood Cells count Above [Month 0]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Red Blood Cells count Below [Month 0]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Red Blood Cells count Unknown [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Red Blood Cells count Normal [Month 7]', 'categories': [{'measurements': [{'value': '457', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}]}]}, {'title': 'Red Blood Cells count Above [Month 7]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Red Blood Cells count Below [Month 7]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Red Blood Cells count Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells count Normal [Month 0]', 'categories': [{'measurements': [{'value': '496', 'groupId': 'OG000'}, {'value': '499', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells count Above [Month 0]', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells count Below [Month 0]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells count Unknown [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells count Normal [Month 7]', 'categories': [{'measurements': [{'value': '440', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells count Above [Month 7]', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells count Below [Month 7]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells count Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin Normal [Month 0]', 'categories': [{'measurements': [{'value': '489', 'groupId': 'OG000'}, {'value': '491', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin Above [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin Below [Month 0]', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin Unknown [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin Normal [Month 7]', 'categories': [{'measurements': [{'value': '441', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin Above [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin Below [Month 7]', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin concentration Normal [Month 0]', 'categories': [{'measurements': [{'value': '495', 'groupId': 'OG000'}, {'value': '488', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin concentration Above [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin concentration Below [Month 0]', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin concentration Unknown [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin concentration Normal [Month 7]', 'categories': [{'measurements': [{'value': '442', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin concentration Above [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin concentration Below [Month 7]', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'MC hemoglobin concentration Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'MC volume Normal [Month 0]', 'categories': [{'measurements': [{'value': '504', 'groupId': 'OG000'}, {'value': '505', 'groupId': 'OG001'}]}]}, {'title': 'MC volume Above [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MC volume Below [Month 0]', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'MC volume Unknown [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MC volume Normal [Month 7]', 'categories': [{'measurements': [{'value': '457', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}]}]}, {'title': 'MC volume Above [Month 7]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'MC volume Below [Month 7]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'MC volume Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 0 and Month 7', 'description': 'Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count.\n\nAbnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Albumin Normal [Month 0]', 'categories': [{'measurements': [{'value': '519', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Above [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Normal [Month 7]', 'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Above [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Below [Month 7]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Albumin Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Albumin/Globulin ratio Normal [Month 0]', 'categories': [{'measurements': [{'value': '483', 'groupId': 'OG000'}, {'value': '488', 'groupId': 'OG001'}]}]}, {'title': 'Albumin/Globulin ratio Above [Month 0]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Albumin/Globulin ratio Below [Month 0]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Albumin/Globulin ratio Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin/Globulin ratio Normal [Month 7]', 'categories': [{'measurements': [{'value': '421', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}]}, {'title': 'Albumin/Globulin ratio Above [Month 7]', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Albumin/Globulin ratio Below [Month 7]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Albumin/Globulin ratio Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase Normal [Month 0]', 'categories': [{'measurements': [{'value': '500', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase Above [Month 0]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase Below [Month 0]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase Normal [Month 7]', 'categories': [{'measurements': [{'value': '451', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase Above [Month 7]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase Below [Month 7]', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'ALT Normal [Month 0]', 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}]}]}, {'title': 'ALT Above [Month 0]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ALT Below [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT Normal [Month 7]', 'categories': [{'measurements': [{'value': '457', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}]}, {'title': 'ALT Above [Month 7]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ALT Below [Month 7]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'AST Normal [Month 0]', 'categories': [{'measurements': [{'value': '516', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}]}]}, {'title': 'AST Above [Month 0]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AST Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST Normal [Month 7]', 'categories': [{'measurements': [{'value': '464', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}]}, {'title': 'AST Above [Month 7]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'AST Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen Normal [Month 0]', 'categories': [{'measurements': [{'value': '450', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen Above [Month 0]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen Below [Month 0]', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen Normal [Month 7]', 'categories': [{'measurements': [{'value': '417', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen Above [Month 7]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen Below [Month 7]', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Normal [Month 0]', 'categories': [{'measurements': [{'value': '516', 'groupId': 'OG000'}, {'value': '519', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Above [Month 0]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Normal [Month 7]', 'categories': [{'measurements': [{'value': '461', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Above [Month 7]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Below [Month 7]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol Normal [Month 0]', 'categories': [{'measurements': [{'value': '407', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol Above [Month 0]', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol Below [Month 0]', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol Normal [Month 7]', 'categories': [{'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol Above [Month 7]', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol Below [Month 7]', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Total cholesterol Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Chlorine Normal [Month 0]', 'categories': [{'measurements': [{'value': '518', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}]}]}, {'title': 'Chlorine Above [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Chlorine Below [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Chlorine Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chlorine Normal [Month 7]', 'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}]}, {'title': 'Chlorine Above [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chlorine Below [Month 7]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Chlorine Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine phosphokinase Normal [Month 0]', 'categories': [{'measurements': [{'value': '456', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine phosphokinase Above [Month 0]', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine phosphokinase Below [Month 0]', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine phosphokinase Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine phosphokinase Normal [Month 7]', 'categories': [{'measurements': [{'value': '412', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine phosphokinase Above [Month 7]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine phosphokinase Below [Month 7]', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine phosphokinase Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Normal [Month 0]', 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Above [Month 0]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Below [Month 0]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Normal [Month 7]', 'categories': [{'measurements': [{'value': '453', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Above [Month 7]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Below [Month 7]', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin Normal [Month 0]', 'categories': [{'measurements': [{'value': '500', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin Above [Month 0]', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin Normal [Month 7]', 'categories': [{'measurements': [{'value': '457', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin Above [Month 7]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'GGT Normal [Month 0]', 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}]}, {'title': 'GGT Above [Month 0]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'GGT Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GGT Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GGT Normal [Month 7]', 'categories': [{'measurements': [{'value': '459', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}]}, {'title': 'GGT Above [Month 7]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'GGT Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GGT Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Normal [Month 0]', 'categories': [{'measurements': [{'value': '468', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Above [Month 0]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Below [Month 0]', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Normal [Month 7]', 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Above [Month 7]', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Below [Month 7]', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Normal [Month 0]', 'categories': [{'measurements': [{'value': '509', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Above [Month 0]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Normal [Month 7]', 'categories': [{'measurements': [{'value': '462', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Above [Month 7]', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Leucine Amino Peptidase Normal [Month 0]', 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}]}]}, {'title': 'Leucine Amino Peptidase Above [Month 0]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Leucine Amino Peptidase Below [Month 0]', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Leucine Amino Peptidase Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leucine Amino Peptidase Normal [Month 7]', 'categories': [{'measurements': [{'value': '460', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}]}, {'title': 'Leucine Amino Peptidase Above [Month 7]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Leucine Amino Peptidase Below [Month 7]', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Leucine Amino Peptidase Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'LDH Normal [Month 0]', 'categories': [{'measurements': [{'value': '486', 'groupId': 'OG000'}, {'value': '491', 'groupId': 'OG001'}]}]}, {'title': 'LDH Above [Month 0]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LDH Below [Month 0]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'LDH Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LDH Normal [Month 7]', 'categories': [{'measurements': [{'value': '433', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}]}, {'title': 'LDH Above [Month 7]', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'LDH Below [Month 7]', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'LDH Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Normal [Month 0]', 'categories': [{'measurements': [{'value': '519', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Above [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Normal [Month 7]', 'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Above [Month 7]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin Normal [Month 0]', 'categories': [{'measurements': [{'value': '472', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin Above [Month 0]', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin Normal [Month 7]', 'categories': [{'measurements': [{'value': '440', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin Above [Month 7]', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Normal [Month 0]', 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Above [Month 0]', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Below [Month 0]', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Normal [Month 7]', 'categories': [{'measurements': [{'value': '275', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Above [Month 7]', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Below [Month 7]', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Total protein Normal [Month 0]', 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}]}]}, {'title': 'Total protein Above [Month 0]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Total protein Below [Month 0]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Total protein Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total protein Normal [Month 7]', 'categories': [{'measurements': [{'value': '454', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}]}]}, {'title': 'Total protein Above [Month 7]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Total protein Below [Month 7]', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Total protein Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid Normal [Month 0]', 'categories': [{'measurements': [{'value': '515', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid Above [Month 0]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid Unknown [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid Normal [Month 7]', 'categories': [{'measurements': [{'value': '465', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid Above [Month 7]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid Unknown [Month 7]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'pH Normal [Month 0]', 'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}]}, {'title': 'pH Above [Month 0]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'pH Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'pH Unknown [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'pH Normal [Month 7]', 'categories': [{'measurements': [{'value': '438', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}]}, {'title': 'pH Above [Month 7]', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'pH Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'pH Unknown [Month 7]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'CRP Normal [Month 0]', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'CRP Above [Month 0]', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'CRP Below [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'CRP Unknown [Month 0]', 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}]}, {'title': 'CRP Normal [Month 7]', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'CRP Above [Month 7]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'CRP Below [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'CRP Unknown [Month 7]', 'categories': [{'measurements': [{'value': '373', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 0 and Month 7', 'description': 'Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined.\n\nAbbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated Cohort.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Protein (-) [Month 0]', 'categories': [{'measurements': [{'value': '496', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}]}]}, {'title': 'Protein (+-) [Month 0]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Protein (+) [Month 0]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Protein (2+) [Month 0]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Protein (3+) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Protein (Unknown) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Protein (-) [Month 7]', 'categories': [{'measurements': [{'value': '444', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}]}, {'title': 'Protein (+-) [Month 7]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Protein (+) [Month 7]', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Protein (2+) [Month 7]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Protein (3+) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Protein (Unknown) [Month 7]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (-) [Month 0]', 'categories': [{'measurements': [{'value': '513', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (+-) [Month 0]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (+) [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (2+) [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (3+) [Month 0]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (Unknown) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (-) [Month 7]', 'categories': [{'measurements': [{'value': '459', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (+-) [Month 7]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (+) [Month 7]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (2+) [Month 7]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (3+) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (Unknown) [Month 7]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (-) [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (+-) [Month 0]', 'categories': [{'measurements': [{'value': '506', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (+) [Month 0]', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (2+) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (3+) [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (Unknown) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (-) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (+-) [Month 7]', 'categories': [{'measurements': [{'value': '460', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (+) [Month 7]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (2+) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (3+) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urobilinogen (Unknown) [Month 7]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (-) [Month 0]', 'categories': [{'measurements': [{'value': '483', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (+-) [Month 0]', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (+) [Month 0]', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (2+) [Month 0]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (3+) [Month 0]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (Unknown) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (-) [Month 7]', 'categories': [{'measurements': [{'value': '393', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (+-) [Month 7]', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (+) [Month 7]', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (2+) [Month 7]', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (3+) [Month 7]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood (Unknown) [Month 7]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (-) [Month 0]', 'categories': [{'measurements': [{'value': '501', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (+-) [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (+) [Month 0]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (2+) [Month 0]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (3+) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (Unknown) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (-) [Month 7]', 'categories': [{'measurements': [{'value': '452', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (+-) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (+) [Month 7]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (2+) [Month 7]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (3+) [Month 7]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ketone Body (Unknown) [Month 7]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (-) [Month 0]', 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (+-) [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (+) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (2+) [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (3+) [Month 0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (Unknown) [Month 0]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (-) [Month 7]', 'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (+-) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (+) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (2+) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (3+) [Month 7]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (Unknown) [Month 7]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 0 and Month 7', 'description': 'Abnormalities in concentrations (expressed as milligrams per deciliter \\[mg/dL\\]) are presented categorical as follows:\n\nProtein: \\<10 (-)\\*; 10-25 (+-)\\*; 25-85 (+); 85-250 (2+); 250-800 (3+).\n\nGlucose: \\<30 (-)\\*; 30-60 (+-)\\*; 60-125 (+); 125-250 (2+); 250-750 (3+).\n\nUrobilinogen: \\<1.5 (+-)\\*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+).\n\nBilirubin: \\<0.35 (-)\\*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+).\n\nOccult blood: \\<0.015 (-)\\*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); \\>0.75 (3+).\n\nKetone body: \\<2.5 (-)\\*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+).\n\nNormal ranges indicated by asterix\\*.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'FG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '519'}, {'groupId': 'FG001', 'numSubjects': '521'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}, {'groupId': 'FG001', 'numSubjects': '436'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '85'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '44'}]}]}], 'preAssignmentDetails': 'Six subjects enrolled in this study were not vaccinated and hence not reported as started in the participant flow table below.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '519', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '1040', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.'}, {'id': 'BG001', 'title': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '22.5', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '22.5', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '519', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '1040', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - Japanese heritage', 'categories': [{'measurements': [{'value': '519', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '1040', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1046}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04-26'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2009-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2006-04-19', 'resultsFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2006-04-19', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-11-12', 'studyFirstPostDateStruct': {'date': '2006-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)', 'timeFrame': 'Throughout the study period (up to Month 24)', 'description': 'Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (\\> 150 days) \\[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\\].'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)', 'timeFrame': 'Up to Month 24', 'description': 'HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6.'}, {'measure': 'Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection', 'timeFrame': 'Up to Month 24', 'description': 'Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.'}, {'measure': 'Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection', 'timeFrame': 'Up to Month 24', 'description': 'Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.'}, {'measure': 'Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types', 'timeFrame': 'Up to Month 24', 'description': 'Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6.\n\nOncogenic (high risk \\[HR\\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.'}, {'measure': 'Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types', 'timeFrame': 'Up to Month 24', 'description': 'Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (\\> 150 days) \\[as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6\\].\n\nOncogenic (high risk \\[HR\\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.'}, {'measure': 'Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type', 'timeFrame': 'Up to Month 24', 'description': 'Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6.\n\nOncogenic (high risk \\[HR\\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.'}, {'measure': 'Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type', 'timeFrame': 'Up to Month 24', 'description': 'Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6.\n\nOncogenic (high risk \\[HR\\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.'}, {'measure': 'Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value', 'timeFrame': 'At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24', 'description': 'Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL.'}, {'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, 6, 7, 12, 18 and 24', '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 Local and General Symptoms', 'timeFrame': 'Within 7 days after each and any vaccination', 'description': 'Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AE)', 'timeFrame': 'Within 30 days after any vaccination', 'description': 'Unsolicited AE covers any AE 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': 'Throughout the study period (up to Month 24)', '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.'}, {'measure': 'Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)', 'timeFrame': 'Throughout the study period (up to Month 24)', 'description': 'NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) 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.'}, {'measure': 'Outcome of Any Reported Pregnancies', 'timeFrame': 'Throughout the study period (up to Month 24)', 'description': 'Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.'}, {'measure': 'Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters', 'timeFrame': 'At Month 0 and Month 7', 'description': 'Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count.\n\nAbnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined.'}, {'measure': 'Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters', 'timeFrame': 'At Month 0 and Month 7', 'description': 'Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined.\n\nAbbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH).'}, {'measure': 'Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples', 'timeFrame': 'At Month 0 and Month 7', 'description': 'Abnormalities in concentrations (expressed as milligrams per deciliter \\[mg/dL\\]) are presented categorical as follows:\n\nProtein: \\<10 (-)\\*; 10-25 (+-)\\*; 25-85 (+); 85-250 (2+); 250-800 (3+).\n\nGlucose: \\<30 (-)\\*; 30-60 (+-)\\*; 60-125 (+); 125-250 (2+); 250-750 (3+).\n\nUrobilinogen: \\<1.5 (+-)\\*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+).\n\nBilirubin: \\<0.35 (-)\\*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+).\n\nOccult blood: \\<0.015 (-)\\*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); \\>0.75 (3+).\n\nKetone body: \\<2.5 (-)\\*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+).\n\nNormal ranges indicated by asterix\\*.'}]}, 'conditionsModule': {'keywords': ['HPV Vaccine Efficacy'], 'conditions': ['Infections, Papillomavirus']}, 'referencesModule': {'availIpds': [{'id': '104798', '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': '104798', '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': '104798', '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': '104798', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '104798', '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': '104798', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '19574783', 'type': 'BACKGROUND', 'citation': 'Konno R, Dobbelaere KO, Godeaux OO, Tamura S, Yoshikawa H. Immunogenicity, reactogenicity, and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women: interim analysis of a phase II, double-blind, randomized controlled trial at month 7. Int J Gynecol Cancer. 2009 Jul;19(5):905-11. doi: 10.1111/IGC.0b013e3181a23c0e.'}, {'pmid': '20375805', 'type': 'BACKGROUND', 'citation': 'Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Efficacy of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: interim analysis of a phase 2 double-blind, randomized, controlled trial. Int J Gynecol Cancer. 2010 Apr;20(3):404-10. doi: 10.1111/IGC.0b013e3181d373a5.'}, {'pmid': '21251162', 'type': 'BACKGROUND', 'citation': 'Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Prevalence and type distribution of human papillomavirus in healthy Japanese women aged 20 to 25 years old enrolled in a clinical study. Cancer Sci. 2011 Apr;102(4):877-82. doi: 10.1111/j.1349-7006.2011.01878.x. Epub 2011 Feb 17.'}, {'type': 'BACKGROUND', 'citation': 'Konno R et al. Efficacy, immunogenicity and safety of HPV 16/18 AS04-adjuvanted vaccine in Japanese women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.'}, {'type': 'BACKGROUND', 'citation': 'Konno R et al. Interim analysis of clinical trial of HPV-16/18-AS04 vaccine in Japan. Abstract presented at the 25th International Papillomavirus Conference, Malmö, Sweden, 8-14 May 2009.'}, {'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.'}, {'pmid': '31824976', 'type': 'DERIVED', 'citation': 'Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec.'}, {'pmid': '25424783', 'type': 'DERIVED', 'citation': 'Konno R, Yoshikawa H, Okutani M, Quint W, V Suryakiran P, Lin L, Struyf F. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women. Hum Vaccin Immunother. 2014;10(7):1781-94. doi: 10.4161/hv.28712.'}, {'pmid': '20606533', 'type': 'DERIVED', 'citation': 'Konno R, Tamura S, Dobbelaere K, Yoshikawa H. Efficacy of human papillomavirus type 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years: final analysis of a phase 2 double-blind, randomized controlled trial. Int J Gynecol Cancer. 2010 Jul;20(5):847-55. doi: 10.1111/IGC.0b013e3181da2128.'}], '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 central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A 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.', 'detailedDescription': 'The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol. Sections impacted are Official Title of the study and Intervention name.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.\n* A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination.\n* Written informed consent obtained from the subject prior to enrolment.\n* Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.\n* Subjects must have a negative urine pregnancy test.\n* Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.\n* Subject must have an intact cervix\n\nExclusion criteria:\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 women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.\n* A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose\n* previous administration of components of the investigational vaccine\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 the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine.\n* Previous vaccination against HPV.\n* History of vaccination against hepatitis A or a known clinical history of hepatitis A disease\n* Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination\n* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines\n* Hypersensitivity to latex\n* Known acute or chronic, clinically significant pulmonary, cardiovascular, 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 having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.\n* Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be performed\n* Acute disease at the time of enrolment.\n* Oral temperature \\>= 37.5°C / axillary temperature \\> 37.5°C.\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).'}, 'identificationModule': {'nctId': 'NCT00316693', 'briefTitle': 'Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.", 'orgStudyIdInfo': {'id': '104798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervarix Group', 'description': 'Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.', 'interventionNames': ['Biological: HPV-16/18 vaccine (Cervarix™)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aimmugen Group', 'description': 'Subjects received 3 doses of Aimmugen™ (Hepatitis A \\[HAV\\] vaccine) according to a 0, 1, 6-month schedule.', 'interventionNames': ['Biological: Aimmugen™']}], 'interventions': [{'name': 'HPV-16/18 vaccine (Cervarix™)', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses', 'armGroupLabels': ['Cervarix Group']}, {'name': 'Aimmugen™', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses', 'armGroupLabels': ['Aimmugen Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '892-0824', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '160-0017', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '183-0056', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'facility': 'GSK Investigational Site'}], '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'}}}}