Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT01165203
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2010-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, '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': 'Solicited local and general symptoms: within 7 days (Days 0-6) post-vaccination. Unsolicited Adverse Events (AEs): within 30 days (Days 0-29) post-vaccination. Serious Adverse Events (SAEs): during the entire study period (from Month 0 up to Month 18).', 'eventGroups': [{'id': 'EG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 72, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 29, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pain', 'notes': 'This solicited local symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Redness', 'notes': 'This solicited local symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Swelling', 'notes': 'This solicited local symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'notes': 'This solicited general symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal', 'notes': 'This solicited general symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'notes': 'This solicited general symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'notes': 'This solicited general symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Shivering', 'notes': 'This solicited general symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Temperature', 'notes': 'This solicited general symptom was only collected from those subjects who had their symptom sheets filled in.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Laryngeal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Portal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 to Month 18', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening (up to 21 days prior to Month 0) until Month 18', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Fatal SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening (up to 21 days prior to Month 0) until Month 18', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Adverse Events (AEs) of Specific Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 until Month 18', 'description': 'AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, 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{'title': 'Grade 3 Gastrointestinal, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature \\[defined as oral/axillary temperature above (\\>) 37.5 degrees Celsius (°C)\\]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Any AE(s)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days (Days 0-29) after each vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Albumin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Conjugated / Direct', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Screening Visit (up to 21 days prior to Month 0)', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Albumin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Conjugated/Direct', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 1', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Albumin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Conjugated/Direct', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 2', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Albumin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Conjugated/Direct', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 3', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Conjugated/Direct', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 6', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Albumin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Conjugated/Direct', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Within', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 7', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Failure to control HIV viral load', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Failure to maintain high CD4 cells count', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 until Month 18', 'description': 'In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any AIDS-defining Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 until Month 18', 'description': 'In this analysis, results were tabulated for the main study groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Change in HIV viral load', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change in CD4 cells count', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 1 to Month 7', 'description': 'In this analysis, results were tabulated for the main study groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG002', 'title': 'ART Low CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG003', 'title': 'ART Low CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG004', 'title': 'Non-ART High CD4 Cohort - GSK 1437173A', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG005', 'title': 'Non-ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Due to failure to control HIV viral load', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Due to failure to maintain high CD4 cells count', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 to Month 18', 'description': 'In this analysis, results were tabulated by HIV status', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any AIDS-defining Condition, by HIV Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG002', 'title': 'ART Low CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG003', 'title': 'ART Low CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG004', 'title': 'Non-ART High CD4 Cohort - GSK 1437173A', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG005', 'title': 'Non-ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 to Month 18', 'description': 'In this analysis, results were tabulated by HIV status', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG002', 'title': 'ART Low CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG003', 'title': 'ART Low CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG004', 'title': 'Non-ART High CD4 Cohort - GSK 1437173A', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG005', 'title': 'Non-ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Change in HIV viral load', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Change in CD4 cells count', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 1 to Month 7', 'description': 'In this analysis, results were tabulated by HIV status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Frequency of gE-specific CD4 T-cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '4684.50', 'spread': '5376.83', 'groupId': 'OG000'}, {'value': '158.64', 'spread': '151.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Month 7', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.', 'unitOfMeasure': 'CD4 T-cells/million T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available at Month 7.'}, {'type': 'PRIMARY', 'title': '-Anti-gE Antibody (Ab) Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '63812.6', 'groupId': 'OG000', 'lowerLimit': '51183.6', 'upperLimit': '79557.7'}, {'value': '1028.4', 'groupId': 'OG001', 'lowerLimit': '658.9', 'upperLimit': '1605.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 7', 'description': '-Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'VZV-specific CD4 [2+] T-cells, pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '750.20', 'spread': '989.36', 'groupId': 'OG000'}, {'value': '835.80', 'spread': '1949.39', 'groupId': 'OG001'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '768.60', 'spread': '739.68', 'groupId': 'OG000'}, {'value': '913.87', 'spread': '2262.66', 'groupId': 'OG001'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '734.09', 'spread': '680.34', 'groupId': 'OG000'}, {'value': '874.13', 'spread': '2027.95', 'groupId': 'OG001'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1878.81', 'spread': '1615.20', 'groupId': 'OG000'}, {'value': '987.24', 'spread': '1988.86', 'groupId': 'OG001'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1646.83', 'spread': '1202.32', 'groupId': 'OG000'}, {'value': '674.20', 'spread': '657.00', 'groupId': 'OG001'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2626.71', 'spread': '2514.40', 'groupId': 'OG000'}, {'value': '1204.44', 'spread': '1911.53', 'groupId': 'OG001'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '995.35', 'spread': '842.96', 'groupId': 'OG000'}, {'value': '531.24', 'spread': '579.63', 'groupId': 'OG001'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '218.26', 'spread': '254.94', 'groupId': 'OG000'}, {'value': '123.15', 'spread': '170.79', 'groupId': 'OG001'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '704.06', 'spread': '614.49', 'groupId': 'OG000'}, {'value': '132.49', 'spread': '213.05', 'groupId': 'OG001'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '649.68', 'spread': '555.51', 'groupId': 'OG000'}, {'value': '140.95', 'spread': '197.99', 'groupId': 'OG001'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3503.69', 'spread': '2971.74', 'groupId': 'OG000'}, {'value': '160.10', 'spread': '220.32', 'groupId': 'OG001'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2647.71', 'spread': '1972.00', 'groupId': 'OG000'}, {'value': '133.70', 'spread': '137.94', 'groupId': 'OG001'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4684.50', 'spread': '5376.83', 'groupId': 'OG000'}, {'value': '158.64', 'spread': '151.15', 'groupId': 'OG001'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1929.30', 'spread': '1603.50', 'groupId': 'OG000'}, {'value': '139.50', 'spread': '219.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Month 0, 1, 2, 3, 6, 7 and 18', 'description': 'The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.', 'unitOfMeasure': 'CD4 T-cells/million T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).'}, {'type': 'SECONDARY', 'title': '-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG002', 'title': 'ART Low CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG003', 'title': 'ART Low CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the 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'categories': [{'measurements': [{'value': '789.48', 'spread': '1037.59', 'groupId': 'OG000'}, {'value': '927.27', 'spread': '2053.32', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '86.96', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG003'}, {'value': '896.13', 'spread': '749.70', 'groupId': 'OG004'}, {'value': '112.66', 'spread': '157.91', 'groupId': 'OG005'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '830.78', 'spread': '775.61', 'groupId': 'OG000'}, {'value': '1049.73', 'spread': '2442.95', 'groupId': 'OG001'}, {'value': '114.79', 'spread': '114.03', 'groupId': 'OG002'}, {'value': '146.91', 'spread': '142.99', 'groupId': 'OG003'}, {'value': '1049.36', 'spread': '546.09', 'groupId': 'OG004'}, {'value': '186.38', 'spread': '31.21', 'groupId': 'OG005'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '716.33', 'spread': '699.22', 'groupId': 'OG000'}, {'value': '991.07', 'spread': '2190.70', 'groupId': 'OG001'}, {'value': '814.64', 'spread': '920.49', 'groupId': 'OG002'}, {'value': '329.96', 'spread': '53.46', 'groupId': 'OG003'}, {'value': '769.13', 'spread': '469.02', 'groupId': 'OG004'}, {'value': '131.90', 'spread': '185.13', 'groupId': 'OG005'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1973.47', 'spread': '1669.57', 'groupId': 'OG000'}, {'value': '1075.62', 'spread': '2186.45', 'groupId': 'OG001'}, {'value': '1804.94', 'spread': '2350.96', 'groupId': 'OG002'}, {'value': '408.18', 'spread': '330.78', 'groupId': 'OG003'}, {'value': '1298.35', 'spread': '725.44', 'groupId': 'OG004'}, {'value': '918.17', 'spread': '1580.86', 'groupId': 'OG005'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1624.32', 'spread': '1161.05', 'groupId': 'OG000'}, {'value': '786.72', 'spread': '657.24', 'groupId': 'OG001'}, {'value': '1996.37', 'spread': '1937.58', 'groupId': 'OG002'}, {'value': '136.42', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG003'}, {'value': '1160.93', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG004'}, {'value': '42.92', 'spread': '37.09', 'groupId': 'OG005'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2285.90', 'spread': '1998.16', 'groupId': 'OG000'}, {'value': '1261.84', 'spread': '1946.12', 'groupId': 'OG001'}, {'value': '6235.67', 'spread': '4334.14', 'groupId': 'OG002'}, {'value': '113.88', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG003'}, {'value': '660.88', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG004'}]}]}, {'title': 'VZV-specific CD4 [2+] T-cells, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1051.12', 'spread': '816.86', 'groupId': 'OG000'}, {'value': '599.00', 'spread': '587.08', 'groupId': 'OG001'}, {'value': '853.05', 'spread': '1235.35', 'groupId': 'OG002'}, {'value': '580.71', 'spread': '683.08', 'groupId': 'OG003'}, {'value': '634.55', 'spread': '933.54', 'groupId': 'OG004'}, {'value': '19.77', 'spread': '22.14', 'groupId': 'OG005'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '215.99', 'spread': '266.22', 'groupId': 'OG000'}, {'value': '136.29', 'spread': '176.85', 'groupId': 'OG001'}, {'value': '51.15', 'spread': '70.92', 'groupId': 'OG002'}, {'value': '1.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG003'}, {'value': '350.86', 'spread': '161.96', 'groupId': 'OG004'}, {'value': '26.57', 'spread': '36.17', 'groupId': 'OG005'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '682.62', 'spread': '595.89', 'groupId': 'OG000'}, {'value': '134.21', 'spread': '224.96', 'groupId': 'OG001'}, {'value': '584.10', 'spread': '652.67', 'groupId': 'OG002'}, {'value': '161.73', 'spread': '227.30', 'groupId': 'OG003'}, {'value': '952.65', 'spread': '763.24', 'groupId': 'OG004'}, {'value': '84.33', 'spread': '117.84', 'groupId': 'OG005'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '610.30', 'spread': '558.27', 'groupId': 'OG000'}, {'value': '157.92', 'spread': '208.48', 'groupId': 'OG001'}, {'value': '960.39', 'spread': '632.86', 'groupId': 'OG002'}, {'value': '94.19', 'spread': '131.79', 'groupId': 'OG003'}, {'value': '629.54', 'spread': '513.99', 'groupId': 'OG004'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG005'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3722.21', 'spread': '2789.70', 'groupId': 'OG000'}, {'value': '190.58', 'spread': '233.81', 'groupId': 'OG001'}, {'value': '4754.94', 'spread': '6004.05', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '1310.76', 'spread': '670.56', 'groupId': 'OG004'}, {'value': '95.71', 'spread': '164.04', 'groupId': 'OG005'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2386.40', 'spread': '1571.28', 'groupId': 'OG000'}, {'value': '152.52', 'spread': '141.50', 'groupId': 'OG001'}, {'value': '5403.79', 'spread': '3326.03', 'groupId': 'OG002'}, {'value': '97.99', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG003'}, {'value': '912.30', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG004'}, {'value': '1.00', 'spread': '0.00', 'groupId': 'OG005'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3649.92', 'spread': '3112.69', 'groupId': 'OG000'}, {'value': '166.94', 'spread': '150.54', 'groupId': 'OG001'}, {'value': '14925.30', 'spread': '10934.07', 'groupId': 'OG002'}, {'value': '1.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG003'}, {'value': '861.21', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG004'}]}]}, {'title': 'gE-specific CD4 [2+] T-cells, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2071.17', 'spread': '1583.58', 'groupId': 'OG000'}, {'value': '159.05', 'spread': '239.50', 'groupId': 'OG001'}, {'value': '2035.18', 'spread': '2100.82', 'groupId': 'OG002'}, {'value': '109.97', 'spread': '93.90', 'groupId': 'OG003'}, {'value': '709.62', 'spread': '1011.03', 'groupId': 'OG004'}, {'value': '24.81', 'spread': '47.63', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Months 0, 1, 2, 3, 6, 7 and 18', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.', 'unitOfMeasure': 'CD4 T-cells/million T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).'}, {'type': 'SECONDARY', 'title': '-Anti-VZV and Anti-gE Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Anti-VZV, Pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1292.7', 'groupId': 'OG000', 'lowerLimit': '999.8', 'upperLimit': '1671.4'}, {'value': '1074.7', 'groupId': 'OG001', 'lowerLimit': '672.7', 'upperLimit': '1717.0'}]}]}, {'title': 'Anti-VZV, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6953.8', 'groupId': 'OG000', 'lowerLimit': '5425.1', 'upperLimit': '8913.3'}, {'value': '1173.8', 'groupId': 'OG001', 'lowerLimit': '762.9', 'upperLimit': '1805.8'}]}]}, {'title': 'Anti-VZV, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5170.9', 'groupId': 'OG000', 'lowerLimit': '4032.7', 'upperLimit': '6630.4'}, {'value': '987.6', 'groupId': 'OG001', 'lowerLimit': '596.3', 'upperLimit': '1635.8'}]}]}, {'title': 'Anti-VZV, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11119.7', 'groupId': 'OG000', 'lowerLimit': '9190.8', 'upperLimit': '13453.3'}, {'value': '1037.8', 'groupId': 'OG001', 'lowerLimit': '620.2', 'upperLimit': '1736.5'}]}]}, {'title': 'Anti-VZV, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8244.0', 'groupId': 'OG000', 'lowerLimit': '6678.6', 'upperLimit': '10176.3'}, {'value': '1069.8', 'groupId': 'OG001', 'lowerLimit': '653.3', 'upperLimit': '1751.7'}]}]}, {'title': 'Anti-VZV, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14560.8', 'groupId': 'OG000', 'lowerLimit': '11849.0', 'upperLimit': '17893.1'}, {'value': '999.3', 'groupId': 'OG001', 'lowerLimit': '598.3', 'upperLimit': '1669.2'}]}]}, {'title': 'Anti-VZV, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7493.3', 'groupId': 'OG000', 'lowerLimit': '5926.7', 'upperLimit': '9473.9'}, {'value': '922.9', 'groupId': 'OG001', 'lowerLimit': '521.1', 'upperLimit': '1634.6'}]}]}, {'title': 'Anti-gE, Pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1218.4', 'groupId': 'OG000', 'lowerLimit': '895.0', 'upperLimit': '1658.7'}, {'value': '849.5', 'groupId': 'OG001', 'lowerLimit': '551.1', 'upperLimit': '1309.4'}]}]}, {'title': 'Anti-gE, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24113.2', 'groupId': 'OG000', 'lowerLimit': '18317.4', 'upperLimit': '31743.0'}, {'value': '1059.0', 'groupId': 'OG001', 'lowerLimit': '749.4', 'upperLimit': '1496.5'}]}]}, {'title': 'Anti-gE, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17112.6', 'groupId': 'OG000', 'lowerLimit': '12929.5', 'upperLimit': '22649.1'}, {'value': '903.3', 'groupId': 'OG001', 'lowerLimit': '590.9', 'upperLimit': '1380.9'}]}]}, {'title': 'Anti-gE, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50443.0', 'groupId': 'OG000', 'lowerLimit': '40899.6', 'upperLimit': '62213.2'}, {'value': '992.9', 'groupId': 'OG001', 'lowerLimit': '647.4', 'upperLimit': '1522.6'}]}]}, {'title': 'Anti-gE, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34159.4', 'groupId': 'OG000', 'lowerLimit': '27221.0', 'upperLimit': '42866.2'}, {'value': '1013.1', 'groupId': 'OG001', 'lowerLimit': '660.5', 'upperLimit': '1553.7'}]}]}, {'title': 'Anti-gE, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63812.6', 'groupId': 'OG000', 'lowerLimit': '51183.6', 'upperLimit': '79557.7'}, {'value': '1028.4', 'groupId': 'OG001', 'lowerLimit': '658.9', 'upperLimit': '1605.0'}]}]}, {'title': 'Anti-gE, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25242.2', 'groupId': 'OG000', 'lowerLimit': '19618.9', 'upperLimit': '32477.3'}, {'value': '918.0', 'groupId': 'OG001', 'lowerLimit': '588.0', 'upperLimit': '1433.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 0, 1, 2, 3, 6, 7 and 18', 'description': 'Antibody concentrations were as determined by ELISA and tabulated for the main study groups. 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Therapy (ART) High CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG002', 'title': 'ART Low CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG003', 'title': 'ART Low CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG004', 'title': 'Non-ART High CD4 Cohort - GSK 1437173A', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG005', 'title': 'Non-ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'Anti-VZV, Pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1161.5', 'groupId': 'OG000', 'lowerLimit': '900.3', 'upperLimit': '1498.6'}, {'value': '985.1', 'groupId': 'OG001', 'lowerLimit': '568.7', 'upperLimit': '1706.4'}, {'value': '2272.6', 'groupId': 'OG002', 'lowerLimit': '559.1', 'upperLimit': '9236.6'}, {'value': '2511.9', 'groupId': 'OG003', 'lowerLimit': '693.0', 'upperLimit': '9104.4'}, {'value': '1658.0', 'groupId': 'OG004', 'lowerLimit': '315.9', 'upperLimit': '8701.1'}, {'value': '1068.5', 'groupId': 'OG005', 'lowerLimit': '117.3', 'upperLimit': '9735.4'}]}]}, {'title': 'Anti-VZV, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7017.8', 'groupId': 'OG000', 'lowerLimit': '5441.2', 'upperLimit': '9051.3'}, {'value': '1059.6', 'groupId': 'OG001', 'lowerLimit': '641.1', 'upperLimit': '1751.2'}, {'value': '6731.0', 'groupId': 'OG002', 'lowerLimit': '572.7', 'upperLimit': '79107.0'}, {'value': '2871.0', 'groupId': 'OG003', 'lowerLimit': '1386.7', 'upperLimit': '5944.3'}, {'value': '6706.0', 'groupId': 'OG004', 'lowerLimit': '2477.9', 'upperLimit': '18148.5'}, {'value': '1167.3', 'groupId': 'OG005', 'lowerLimit': '130.1', 'upperLimit': '10475.4'}]}]}, {'title': 'Anti-VZV, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5056.5', 'groupId': 'OG000', 'lowerLimit': '3973.9', 'upperLimit': '6434.0'}, {'value': '886.9', 'groupId': 'OG001', 'lowerLimit': '498.6', 'upperLimit': '1577.4'}, {'value': '5649.6', 'groupId': 'OG002', 'lowerLimit': '418.4', 'upperLimit': '76276.9'}, {'value': '2902.1', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '4493973'}, {'value': '6100.0', 'groupId': 'OG004', 'lowerLimit': '480.4', 'upperLimit': '77462.7'}, {'value': '1191.1', 'groupId': 'OG005', 'lowerLimit': '119.6', 'upperLimit': '11860.7'}]}]}, {'title': 'Anti-VZV, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11631.9', 'groupId': 'OG000', 'lowerLimit': '9523.8', 'upperLimit': '14206.6'}, {'value': '1002.7', 'groupId': 'OG001', 'lowerLimit': '565.8', 'upperLimit': '1777.1'}, {'value': '9110.7', 'groupId': 'OG002', 'lowerLimit': '2224.8', 'upperLimit': '37308.9'}, {'value': '2479.3', 'comment': 'There were not enough subjects for a Lower Limit (LL) and Upper Limit (UL) to be computed.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8990.7', 'groupId': 'OG004', 'lowerLimit': '5233.1', 'upperLimit': '15446.6'}, {'value': '1062.0', 'groupId': 'OG005', 'lowerLimit': '81.1', 'upperLimit': '13906.2'}]}]}, {'title': 'Anti-VZV, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9027.6', 'groupId': 'OG000', 'lowerLimit': '7225.1', 'upperLimit': '11279.6'}, {'value': '957.0', 'groupId': 'OG001', 'lowerLimit': '537.2', 'upperLimit': '1705.0'}, {'value': '7634.7', 'groupId': 'OG002', 'lowerLimit': '2054.6', 'upperLimit': '28369.5'}, {'value': '3164.8', 'groupId': 'OG003', 'lowerLimit': '510.5', 'upperLimit': '19621.7'}, {'value': '4384.3', 'groupId': 'OG004', 'lowerLimit': '2322.5', 'upperLimit': '8276.5'}, {'value': '1006.3', 'groupId': 'OG005', 'lowerLimit': '115.7', 'upperLimit': '8754.6'}]}]}, {'title': 'Anti-VZV, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '15278.5', 'groupId': 'OG000', 'lowerLimit': '12420.2', 'upperLimit': '18794.5'}, {'value': '930.5', 'groupId': 'OG001', 'lowerLimit': '511.6', 'upperLimit': '1692.3'}, {'value': '14763.2', 'groupId': 'OG002', 'lowerLimit': '2859.6', 'upperLimit': '76216.1'}, {'value': '2177.3', 'groupId': 'OG003', 'lowerLimit': '8.7', 'upperLimit': '544573.1'}, {'value': '8845.8', 'groupId': 'OG004', 'lowerLimit': '5463.6', 'upperLimit': '14321.5'}, {'value': '1076.7', 'groupId': 'OG005', 'lowerLimit': '109.5', 'upperLimit': '10591.1'}]}]}, {'title': 'Anti-VZV, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8242.2', 'groupId': 'OG000', 'lowerLimit': '6484.1', 'upperLimit': '10476.9'}, {'value': '838.1', 'groupId': 'OG001', 'lowerLimit': '435.9', 'upperLimit': '1611.5'}, {'value': '6106.2', 'groupId': 'OG002', 'lowerLimit': '748.6', 'upperLimit': '49809.5'}, {'value': '1955.3', 'groupId': 'OG003', 'lowerLimit': '188.8', 'upperLimit': '20249.5'}, {'value': '4361.7', 'groupId': 'OG004', 'lowerLimit': '1721.5', 'upperLimit': '11050.9'}, {'value': '1209.2', 'groupId': 'OG005', 'lowerLimit': '13.9', 'upperLimit': '105230.8'}]}]}, {'title': 'Anti-gE, Pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1113.2', 'groupId': 'OG000', 'lowerLimit': '794.3', 'upperLimit': '1560.3'}, {'value': '791.0', 'groupId': 'OG001', 'lowerLimit': '490.7', 'upperLimit': '1275.1'}, {'value': '1845.1', 'groupId': 'OG002', 'lowerLimit': '465.1', 'upperLimit': '7319.1'}, {'value': '2420.7', 'groupId': 'OG003', 'lowerLimit': '512.0', 'upperLimit': '11445.2'}, {'value': '1748.6', 'groupId': 'OG004', 'lowerLimit': '308.5', 'upperLimit': '9912.2'}, {'value': '661.2', 'groupId': 'OG005', 'lowerLimit': '43.8', 'upperLimit': '9984.8'}]}]}, {'title': 'Anti-gE, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '25530.6', 'groupId': 'OG000', 'lowerLimit': '19158.6', 'upperLimit': '34021.9'}, {'value': '1029.5', 'groupId': 'OG001', 'lowerLimit': '719.5', 'upperLimit': '1473.1'}, {'value': '18767.2', 'groupId': 'OG002', 'lowerLimit': '2219.4', 'upperLimit': '158697.1'}, {'value': '2328.1', 'groupId': 'OG003', 'lowerLimit': '446.4', 'upperLimit': '12141.8'}, {'value': '18742.3', 'groupId': 'OG004', 'lowerLimit': '6616.7', 'upperLimit': '53089.1'}, {'value': '720.0', 'groupId': 'OG005', 'lowerLimit': '50.6', 'upperLimit': '10238.5'}]}]}, {'title': 'Anti-gE, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18208.6', 'groupId': 'OG000', 'lowerLimit': '13537.4', 'upperLimit': '24491.6'}, {'value': '839.8', 'groupId': 'OG001', 'lowerLimit': '524.6', 'upperLimit': '1344.4'}, {'value': '13106.4', 'groupId': 'OG002', 'lowerLimit': '1619.0', 'upperLimit': '106104.2'}, {'value': '2465.5', 'groupId': 'OG003', 'lowerLimit': '561.9', 'upperLimit': '10817.4'}, {'value': '13100.6', 'groupId': 'OG004', 'lowerLimit': '4828.6', 'upperLimit': '35543.7'}, {'value': '735.0', 'groupId': 'OG005', 'lowerLimit': '52.7', 'upperLimit': '10245.9'}]}]}, {'title': 'Anti-gE, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '54777.7', 'groupId': 'OG000', 'lowerLimit': '44077.1', 'upperLimit': '68076.1'}, {'value': '955.6', 'groupId': 'OG001', 'lowerLimit': '590.6', 'upperLimit': '1546.2'}, {'value': '36592.6', 'groupId': 'OG002', 'lowerLimit': '7026.0', 'upperLimit': '190581.1'}, {'value': '2166.3', 'groupId': 'OG003', 'lowerLimit': '618.9', 'upperLimit': '7583.1'}, {'value': '33662.4', 'groupId': 'OG004', 'lowerLimit': '20665.6', 'upperLimit': '54833.0'}, {'value': '736.6', 'groupId': 'OG005', 'lowerLimit': '52.1', 'upperLimit': '10414.5'}]}]}, {'title': 'Anti-gE, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38068.2', 'groupId': 'OG000', 'lowerLimit': '29964.3', 'upperLimit': '48363.7'}, {'value': '932.8', 'groupId': 'OG001', 'lowerLimit': '582.6', 'upperLimit': '1493.3'}, {'value': '24725.0', 'groupId': 'OG002', 'lowerLimit': '5143.2', 'upperLimit': '118862.3'}, {'value': '2629.2', 'groupId': 'OG003', 'lowerLimit': '561.7', 'upperLimit': '12306.8'}, {'value': '18189.6', 'groupId': 'OG004', 'lowerLimit': '11258.0', 'upperLimit': '29389.0'}, {'value': '920.6', 'groupId': 'OG005', 'lowerLimit': '54.8', 'upperLimit': '15461.5'}]}]}, {'title': 'Anti-gE, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '71309.6', 'groupId': 'OG000', 'lowerLimit': '57019.3', 'upperLimit': '89181.5'}, {'value': '928.8', 'groupId': 'OG001', 'lowerLimit': '566.8', 'upperLimit': '1522.1'}, {'value': '47382.6', 'groupId': 'OG002', 'lowerLimit': '9151.2', 'upperLimit': '245336.2'}, {'value': '2553.0', 'groupId': 'OG003', 'lowerLimit': '610.1', 'upperLimit': '10683.1'}, {'value': '32334.6', 'groupId': 'OG004', 'lowerLimit': '17277.6', 'upperLimit': '60513.4'}, {'value': '1087.6', 'groupId': 'OG005', 'lowerLimit': '60.2', 'upperLimit': '19641.4'}]}]}, {'title': 'Anti-gE, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '28854.6', 'groupId': 'OG000', 'lowerLimit': '22512.5', 'upperLimit': '36983.3'}, {'value': '849.4', 'groupId': 'OG001', 'lowerLimit': '514.6', 'upperLimit': '1401.9'}, {'value': '18995.8', 'groupId': 'OG002', 'lowerLimit': '1733.3', 'upperLimit': '208181.4'}, {'value': '1953.7', 'groupId': 'OG003', 'lowerLimit': '572.7', 'upperLimit': '6665.3'}, {'value': '10869.2', 'groupId': 'OG004', 'lowerLimit': '4435.4', 'upperLimit': '26635.7'}, {'value': '757.8', 'groupId': 'OG005', 'lowerLimit': '34.8', 'upperLimit': '16519.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 0, 1, 2, 3, 6, 7 and 18', 'description': 'Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Month 0 until Month 18', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG002', 'title': 'ART Low CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG003', 'title': 'ART Low CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG004', 'title': 'Non-ART High CD4 Cohort - GSK 1437173A', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG005', 'title': 'Non-ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'CD4+, pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '631.46', 'spread': '236.36', 'groupId': 'OG000'}, {'value': '683.39', 'spread': '228.29', 'groupId': 'OG001'}, {'value': '152.11', 'spread': '38.39', 'groupId': 'OG002'}, {'value': '132.20', 'spread': '11.19', 'groupId': 'OG003'}, {'value': '805.33', 'spread': '132.38', 'groupId': 'OG004'}, {'value': '901.67', 'spread': '177.61', 'groupId': 'OG005'}]}]}, {'title': 'CD4+, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '630.55', 'spread': '241.78', 'groupId': 'OG000'}, {'value': '694.69', 'spread': '307.98', 'groupId': 'OG001'}, {'value': '151.11', 'spread': '38.72', 'groupId': 'OG002'}, {'value': '163.00', 'spread': '53.66', 'groupId': 'OG003'}, {'value': '879.67', 'spread': '277.37', 'groupId': 'OG004'}, {'value': '773.40', 'spread': '144.85', 'groupId': 'OG005'}]}]}, {'title': 'CD4+, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '667.69', 'spread': '309.22', 'groupId': 'OG000'}, {'value': '656.14', 'spread': '262.43', 'groupId': 'OG001'}, {'value': '131.13', 'spread': '39.57', 'groupId': 'OG002'}, {'value': '133.75', 'spread': '31.86', 'groupId': 'OG003'}, {'value': '808.75', 'spread': '211.32', 'groupId': 'OG004'}, {'value': '804.00', 'spread': '199.09', 'groupId': 'OG005'}]}]}, {'title': 'CD4+, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '633.60', 'spread': '228.75', 'groupId': 'OG000'}, {'value': '640.14', 'spread': '238.05', 'groupId': 'OG001'}, {'value': '153.11', 'spread': '54.27', 'groupId': 'OG002'}, {'value': '142.60', 'spread': '36.49', 'groupId': 'OG003'}, {'value': '783.63', 'spread': '239.92', 'groupId': 'OG004'}, {'value': '762.60', 'spread': '185.66', 'groupId': 'OG005'}]}]}, {'title': 'CD4+, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '655.02', 'spread': '264.67', 'groupId': 'OG000'}, {'value': '668.28', 'spread': '308.64', 'groupId': 'OG001'}, {'value': '145.33', 'spread': '29.74', 'groupId': 'OG002'}, {'value': '145.20', 'spread': '43.18', 'groupId': 'OG003'}, {'value': '776.43', 'spread': '303.30', 'groupId': 'OG004'}, {'value': '1082.80', 'spread': '649.82', 'groupId': 'OG005'}]}]}, {'title': 'CD4+, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '654.69', 'spread': '271.31', 'groupId': 'OG000'}, {'value': '658.81', 'spread': '246.53', 'groupId': 'OG001'}, {'value': '170.25', 'spread': '44.52', 'groupId': 'OG002'}, {'value': '150.40', 'spread': '35.11', 'groupId': 'OG003'}, {'value': '869.14', 'spread': '297.04', 'groupId': 'OG004'}, {'value': '866.00', 'spread': '144.30', 'groupId': 'OG005'}]}]}, {'title': 'CD4+, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '679.71', 'spread': '247.57', 'groupId': 'OG000'}, {'value': '651.06', 'spread': '247.30', 'groupId': 'OG001'}, {'value': '168.43', 'spread': '58.49', 'groupId': 'OG002'}, {'value': '151.40', 'spread': '57.48', 'groupId': 'OG003'}, {'value': '720.00', 'spread': '228.77', 'groupId': 'OG004'}, {'value': '824.40', 'spread': '207.57', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18', 'description': 'CD4 count was tabulated by HIV status.', 'unitOfMeasure': 'CD4 T-cells/million T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'HIV VL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG001', 'title': 'ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG002', 'title': 'ART Low CD4 Cohort - GSK 1437173A', 'description': 'ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG003', 'title': 'ART Low CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG004', 'title': 'Non-ART High CD4 Cohort - GSK 1437173A', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'OG005', 'title': 'Non-ART High CD4 Cohort - Placebo', 'description': 'ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'classes': [{'title': 'HIV VL, pre-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '62.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG002'}, {'value': '23014.11', 'spread': '18435.10', 'groupId': 'OG004'}, {'value': '16022.17', 'spread': '23652.18', 'groupId': 'OG005'}]}]}, {'title': 'HIV VL, Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '42.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG000'}, {'value': '48.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG002'}, {'value': '24538.89', 'spread': '19056.10', 'groupId': 'OG004'}, {'value': '14415.80', 'spread': '9289.92', 'groupId': 'OG005'}]}]}, {'title': 'HIV VL, Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '48.67', 'spread': '10.79', 'groupId': 'OG000'}, {'value': '55.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG001'}, {'value': '48.00', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '24134.25', 'spread': '13753.92', 'groupId': 'OG004'}, {'value': '18188.25', 'spread': '15199.35', 'groupId': 'OG005'}]}]}, {'title': 'HIV VL, Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '75.00', 'spread': '37.75', 'groupId': 'OG000'}, {'value': '84.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG002'}, {'value': '19453.50', 'spread': '11878.74', 'groupId': 'OG004'}, {'value': '16270.00', 'spread': '15785.91', 'groupId': 'OG005'}]}]}, {'title': 'HIV VL, Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '19699.25', 'spread': '39272.50', 'groupId': 'OG000'}, {'value': '112.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG001'}, {'value': '66053.50', 'spread': '93328.90', 'groupId': 'OG002'}, {'value': '51.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG003'}, {'value': '37091.29', 'spread': '33678.60', 'groupId': 'OG004'}, {'value': '46429.60', 'spread': '52567.42', 'groupId': 'OG005'}]}]}, {'title': 'HIV VL, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '530.67', 'spread': '785.50', 'groupId': 'OG000'}, {'value': '55.75', 'spread': '6.29', 'groupId': 'OG001'}, {'value': '248.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG002'}, {'value': '35534.00', 'spread': '39549.42', 'groupId': 'OG004'}, {'value': '25774.60', 'spread': '27360.66', 'groupId': 'OG005'}]}]}, {'title': 'HIV VL, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '70.33', 'spread': '29.54', 'groupId': 'OG000'}, {'value': '92.67', 'spread': '64.53', 'groupId': 'OG001'}, {'value': '48.00', 'spread': 'NA', 'comment': 'There were not enough subjects for SD analysis to be computed.', 'groupId': 'OG002'}, {'value': '60597.00', 'spread': '48313.15', 'groupId': 'OG004'}, {'value': '14742.60', 'spread': '18306.17', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18', 'description': 'HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.', 'unitOfMeasure': 'HIV-RNA copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included only vaccinated subjects with at least one vaccine administration documented, who had available results of ≥ 40 copies/mL.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}], 'periods': [{'title': 'Active Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Extended Safety Follow-up Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other-subjects business reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '10.68', 'groupId': 'BG000'}, {'value': '45.1', 'spread': '11.36', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '10.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African heritage/African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Asian-East Asian heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian-Japanese heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White-Caucasian/European heritage', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'Unspecified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2013-04-11', 'completionDateStruct': {'date': '2013-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2010-07-15', 'dispFirstSubmitQcDate': '2013-04-11', 'resultsFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2010-07-15', 'dispFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-11', 'studyFirstPostDateStruct': {'date': '2010-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From Month 0 to Month 18', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine', 'timeFrame': 'From screening (up to 21 days prior to Month 0) until Month 18', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Any Fatal SAEs', 'timeFrame': 'From screening (up to 21 days prior to Month 0) until Month 18', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Any Adverse Events (AEs) of Specific Interest', 'timeFrame': 'From Month 0 until Month 18', 'description': 'AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms', 'timeFrame': 'Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature \\[defined as oral/axillary temperature above (\\>) 37.5 degrees Celsius (°C)\\]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Unsolicited AEs', 'timeFrame': 'Within 30 days (Days 0-29) after each vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'timeFrame': 'At Screening Visit (up to 21 days prior to Month 0)', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.'}, {'measure': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'timeFrame': 'At Month 1', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.'}, {'measure': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'timeFrame': 'At Month 2', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.'}, {'measure': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'timeFrame': 'At Month 3', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.'}, {'measure': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'timeFrame': 'At Month 6', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.'}, {'measure': 'Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges', 'timeFrame': 'At Month 7', 'description': 'The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.'}, {'measure': 'Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects', 'timeFrame': 'From Month 0 until Month 18', 'description': 'In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.'}, {'measure': 'Number of Subjects With Any AIDS-defining Condition', 'timeFrame': 'From Month 0 until Month 18', 'description': 'In this analysis, results were tabulated for the main study groups.'}, {'measure': 'Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count', 'timeFrame': 'From Month 1 to Month 7', 'description': 'In this analysis, results were tabulated for the main study groups.'}, {'measure': 'Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status', 'timeFrame': 'From Month 0 to Month 18', 'description': 'In this analysis, results were tabulated by HIV status'}, {'measure': 'Number of Subjects With Any AIDS-defining Condition, by HIV Status', 'timeFrame': 'From Month 0 to Month 18', 'description': 'In this analysis, results were tabulated by HIV status'}, {'measure': 'Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status', 'timeFrame': 'From Month 1 to Month 7', 'description': 'In this analysis, results were tabulated by HIV status.'}, {'measure': 'Frequency of gE-specific CD4 T-cells', 'timeFrame': 'At Month 7', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.'}, {'measure': '-Anti-gE Antibody (Ab) Concentrations', 'timeFrame': 'At Month 7', 'description': '-Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).'}], 'secondaryOutcomes': [{'measure': '-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells', 'timeFrame': 'At Month 0, 1, 2, 3, 6, 7 and 18', 'description': 'The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.'}, {'measure': '-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status', 'timeFrame': 'At Months 0, 1, 2, 3, 6, 7 and 18', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.'}, {'measure': '-Anti-VZV and Anti-gE Antibody Concentrations', 'timeFrame': 'At Months 0, 1, 2, 3, 6, 7 and 18', 'description': 'Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.'}, {'measure': '-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status', 'timeFrame': 'At Months 0, 1, 2, 3, 6, 7 and 18', 'description': 'Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.'}, {'measure': 'Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications', 'timeFrame': 'From Month 0 until Month 18'}, {'measure': 'CD4 Count', 'timeFrame': 'At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18', 'description': 'CD4 count was tabulated by HIV status.'}, {'measure': 'HIV VL', 'timeFrame': 'At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18', 'description': 'HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.'}]}, 'conditionsModule': {'keywords': ['immunogenicity', 'vaccine', 'safety', 'HIV', 'Herpes Zoster'], 'conditions': ['Herpes Zoster']}, 'referencesModule': {'availIpds': [{'id': '112673', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112673', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112673', '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': '112673', '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': '112673', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112673', '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': '112673', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '25371534', 'type': 'DERIVED', 'citation': 'Berkowitz EM, Moyle G, Stellbrink HJ, Schurmann D, Kegg S, Stoll M, El Idrissi M, Oostvogels L, Heineman TC; Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 2015 Apr 15;211(8):1279-87. doi: 10.1093/infdis/jiu606. Epub 2014 Nov 3.'}], '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': "This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts.\n\nThis Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted sections is exclusion criteria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that they can and will comply with the requirements of the protocol;\n* Male and female subjects at least 18 years old at the time of vaccination;\n* Subjects born before 1985 and not from a tropical region. Subjects born in 1985 or later and subjects born before 1985 in tropical regions must have a history of Varicella Zoster virus (VZV) infection or serological evidence of prior VZV infection;\n* Written informed consent obtained from the subject;\n* Female subjects of non-childbearing potential may be enrolled in the study; Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.\n\nOR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;\n\n* Known to be human immunodeficiency virus-1 (HIV-1) infected, diagnosed at least 1 year prior to enrolment;\n* For the antiretroviral therapyART High CD4 and ART Low CD4 cohorts:\n\n * Stable on ART for at least one year\n * CD4 T cell count \\>= 50 cells /mm3 at screening\n * Undetectable VL at screening;\n* For the non-ART High CD4 cohort:\n\n * ART-naïve subjects who have never received anti-retroviral therapy after HIV diagnosis and for whom commencement of ART is not expected based on current assessment within next seven months;\n * HIV VL \\>= 1000 copies/mL and \\<= 100 000 copies/mL at screening\n * CD4 T cell count \\>= 500 cells/mm3 at screening.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period;\n* Vaccination against varicella or herpes zoster (HZ) within the previous 12 months;\n* Occurrence of a varicella or HZ episode within the previous 12 months;\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation. Please note, the vaccine and vials in this study do not contain latex;\n* Has currently an Acquired Immunodeficiency Syndrome (AIDS) defining condition;\n* Opportunistic infection or AIDS-associated malignancy in the previous year;\n* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease other than HIV infection or immunosuppressive/cytotoxic therapy;\n* Administration of immunoglobulins, and/or any blood products within 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period;\n* Chronic administration of immunosuppressive or other immune-modifying drugs within 6 months prior to the first vaccine dose;\n* Administration and/or planned administration of a vaccine not foreseen by the study protocol within 30 days before dose 1, dose 2 and/or 3 of vaccine and/or within 30 days after any dose. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1, 2 and/or 3, and/or at least 14 days after any dose of study vaccine;\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;\n* Acute disease at the time of enrolment;\n* Any contraindication to receiving intramuscular injections;\n* Any condition or illness which might interfere with the evaluation of the safety or immunogenicity of the vaccine;\n* Active hepatitis B (HBV) infection or active hepatitis C (HCV) infection.\n* Current use of HIV fusion inhibitors, chemokine (C-C motif) receptor (CCR5) inhibitors or Interleukin-2/ Interleukin-7/ Interferon;\n* For subjects in the ART cohorts, any change in anti-retroviral drug regimen within 12 weeks prior to vaccination;\n* Pregnant or lactating female;\n* Female planning to become pregnant or planning to discontinue contraceptive precautions;\n* Abnormal biochemical and hematological laboratory values obtained for blood samples collected at screening.'}, 'identificationModule': {'nctId': 'NCT01165203', 'briefTitle': "Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A in Adult HIV-infected Subjects", 'orgStudyIdInfo': {'id': '112673'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK1437173A Group', 'description': 'Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.', 'interventionNames': ['Biological: Herpes Zoster Vaccine GSK1437173A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Herpes Zoster Vaccine GSK1437173A', 'type': 'BIOLOGICAL', 'otherNames': ['HZ/su vaccine'], 'description': 'intramuscular injection', 'armGroupLabels': ['GSK1437173A Group']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'intramuscular injection', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '87505', 'city': 'Santa Fe', 'state': 'New Mexico', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.68698, 'lon': -105.9378}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '44791', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '40237', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20146', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'SE18 4QH', 'city': 'Woolwich, London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site'}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9TH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], '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'}}}}