Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 10:29 AM
Study NCT ID:
NCT00707967
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2008-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'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/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.', 'eventGroups': [{'id': 'EG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.', 'otherNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cd4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pterygium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'notes': 'Solicited general symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'notes': 'Solicited general symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Temperature (Axillary)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Dose 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Dose 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Dose 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain, Dose 2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Dose 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Dose 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Pain, Across', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Pain, Across', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Redness, Across', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Redness, Across', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling, Across', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling, Across', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-day period (Days 0-6) post vaccination following each dose', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'Any Fatigue, Dose 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fatigue, Dose 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Fatigue, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Gastro, Dose 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Gastro, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Gastro, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Headache, Dose 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Headache, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Headache, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Malaise, Dose 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Malaise, Dose 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Malaise, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Myalgia, Dose 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Myalgia, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Myalgia, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature, Dose 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Fatigue, Dose 2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fatigue, Dose 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Fatigue, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Gastro, Dose 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Gastro, Dose 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Gastro, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Headache, Dose 2', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Headache, Dose 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Headache, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Malaise, Dose 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Malaise, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Malaise, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Myalgia, Dose 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Myalgia, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Myalgia, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature, Dose 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature, Dose 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Fatigue, Across', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fatigue, Across', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Fatigue, Across', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Gastro, Across', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Gastro, Across', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Gastro, Across', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Headache, Across', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Headache, Across', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Headache, Across', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Malaise, Across', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Malaise, Across', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Malaise, Across', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Myalgia, Across', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Myalgia, Across', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Myalgia, Across', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature, Across', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature, Across', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature, Across', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-day period (Days 0-6) post vaccination following each dose', 'description': 'Assessed solicited general symptoms were fatigue, temperature \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\], gastrointestinal symptoms (gastro) \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 30-day period (Days 0-29) post 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 out-side 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': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period, from Day 0 up to Day 210', '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': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Normal Biochemical and Haematological Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'ALT, Day 0-normal', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 7-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 30-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 37-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 60-normal', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 0-normal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 7-normal', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 30-normal', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 37-normal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 60-normal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 0-normal', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 7-normal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 30-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 37-normal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 60-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 0-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 7-normal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 30-normal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 37-normal', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 60-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 0-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 7-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 30-normal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 37-normal', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 60-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], basophils \\[BAS\\], creatinine \\[CREA\\], eosinophil \\[EOS\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Normal Haematological Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'Hct, Day 0-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 7-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 30-normal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 37-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 60-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 0-normal', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 7-normal', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 30-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 37-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 60-normal', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 0-normal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 7-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 30-normal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 37-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 60-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 0-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 7-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 30-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 37-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 60-normal', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 0-normal', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 7-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 30-normal', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 37-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 60-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were haematocrit \\[Hct\\], haemoglobin \\[Hgb\\], lymphocytes \\[LYM\\], monocytes \\[MON\\], neutrophils \\[NEU\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Normal Haematological Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'PLA, Day 0-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 7-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 30-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 37-normal', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 60-normal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 0-normal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 7-normal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 30-normal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 37-normal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 60-normal', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 0-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 7-normal', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 30-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 37-normal', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 60-normal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were platelets \\[PLA\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Biochemical and Haematological Levels Below Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'ALT, Day 0-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 7-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 30-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 37-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 60-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 0-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 7-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 30-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 37-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 60-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 0-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 7-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 30-below', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 37-below', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 60-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 0-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 7-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 30-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 37-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 60-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 0-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 7-below', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 30-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 37-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 60-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], basophils \\[BAS\\], creatinine \\[CREA\\], eosinophil \\[EOS\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Haematological Levels Below Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'Hct, Day 0-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 7-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 30-below', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 37-below', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 60-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 0-below', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 7-below', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 30-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 37-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 60-below', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 0-below', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 7-below', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 30-below', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 37-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 60-below', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 0-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 7-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 30-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 37-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 60-below', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 0-below', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 7-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 30-below', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 37-below', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 60-below', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were haematocrit \\[Hct\\], haemoglobin \\[Hgb\\], lymphocytes \\[LYM\\], monocytes \\[MON\\], neutrophils \\[NEU\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Haematological Levels Below Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'PLA, Day 0-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 7-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 30-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 37-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 60-below', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 0-below', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 7-below', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 30-below', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 37-below', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 60-below', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 0-below', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 7-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 30-below', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 37-below', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 60-below', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were \\[PLA\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Biochemical and Haematological Levels Above Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'ALT, Day 0-above', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 7-above', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 30-above', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 37-above', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT, Day 60-above', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 0-above', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 7-above', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 30-above', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 37-above', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AST, Day 60-above', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 0-above', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 7-above', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 30-above', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 37-above', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'BAS, Day 60-above', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 0-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 7-above', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 30-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 37-above', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'CREA, Day 60-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 0-above', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 7-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 30-above', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 37-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'EOS, Day 60-above', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], basophils \\[BAS\\], creatinine \\[CREA\\], eosinophil \\[EOS\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Haematological Levels Above Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'Hct, Day 0-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 7-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 30-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 37-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hct, Day 60-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 0-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 7-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 30-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 37-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hgb, Day 60-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 0-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 7-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 30-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 37-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'LYM, Day 60-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 0-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 7-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 30-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 37-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'MON, Day 60-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 0-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 7-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 30-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 37-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NEU, Day 60-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were haematocrit \\[Hct\\], haemoglobin \\[Hgb\\], lymphocytes \\[LYM\\], monocytes \\[MON\\], neutrophils \\[NEU\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Haematological Levels Above Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'PLA, Day 0-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 7-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 30-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 37-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'PLA, Day 60-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 0-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 7-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 30-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 37-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'RBC, Day 60-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 0-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 7-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 30-above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 37-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'WBC, Day 60-above', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were \\[PLA\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'CD4-All Doubles, Day 0 [N=22;8;7]', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '218.0'}, {'value': '154.5', 'groupId': 'OG001', 'lowerLimit': '40.5', 'upperLimit': '160.5'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '267.0'}]}]}, {'title': 'CD4-All Doubles, Day 30 [N=22;8;7]', 'categories': [{'measurements': [{'value': '1713.5', 'groupId': 'OG000', 'lowerLimit': '507.0', 'upperLimit': '2786.0'}, {'value': '129.0', 'groupId': 'OG001', 'lowerLimit': '103.5', 'upperLimit': '204.5'}, {'value': '94.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '226.0'}]}]}, {'title': 'CD4-All Doubles, Day 60 [N=22;8;7]', 'categories': [{'measurements': [{'value': '7003.5', 'groupId': 'OG000', 'lowerLimit': '3691.0', 'upperLimit': '10701.0'}, {'value': '112.0', 'groupId': 'OG001', 'lowerLimit': '51.0', 'upperLimit': '258.0'}, {'value': '26.0', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '227.0'}]}]}, {'title': 'CD4-All Doubles, Day 210 [N=21;8;7]', 'categories': [{'measurements': [{'value': '4245.0', 'groupId': 'OG000', 'lowerLimit': '2427.0', 'upperLimit': '6121.0'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '140.0'}, {'value': '67.0', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '133.0'}]}]}, {'title': 'CD8-All Doubles, Day 0 [N=22;8;7]', 'categories': [{'measurements': [{'value': '167.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '358.0'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '442.0'}, {'value': '364.0', 'groupId': 'OG002', 'lowerLimit': '80.0', 'upperLimit': '1001.0'}]}]}, {'title': 'CD8-All Doubles, Day 30 [N=22;8;7]', 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '507.0'}, {'value': '38.5', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '293.0'}, {'value': '216.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '986.0'}]}]}, {'title': 'CD8-All Doubles, Day 60 [N=22;8;7]', 'categories': [{'measurements': [{'value': '236.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '542.0'}, {'value': '74.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '570.0'}, {'value': '415.0', 'groupId': 'OG002', 'lowerLimit': '25.0', 'upperLimit': '889.0'}]}]}, {'title': 'CD8-All Doubles, Day 210 [N=21;8;7]', 'categories': [{'measurements': [{'value': '195.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '340.0'}, {'value': '55.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '248.5'}, {'value': '241.0', 'groupId': 'OG002', 'lowerLimit': '39.0', 'upperLimit': '858.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, 30, 60 and 210', 'description': 'Among cytokines expressed were interleukin-2 \\[IL-2\\] and/or interferon-gamma \\[IFN-γ\\] and/or tumour necrosis factor-alpha \\[TNF-α\\] and/or cluster of differentiation 40-ligand \\[CD40-L\\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).', 'unitOfMeasure': 'T cells/million cells', 'dispersionType': 'Inter-Quartile Range', '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 outcome variables were available.'}, {'type': 'SECONDARY', 'title': 'Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'CD4-CD40-L, Day 0 [N=22;8;7]', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '185.0'}, {'value': '135.0', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '152.0'}, {'value': '110.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '240.0'}]}]}, {'title': 'CD4-CD40-L, Day 30 [N=22;8;7]', 'categories': [{'measurements': [{'value': '1389.5', 'groupId': 'OG000', 'lowerLimit': '506.0', 'upperLimit': '2359.0'}, {'value': '129.0', 'groupId': 'OG001', 'lowerLimit': '71.5', 'upperLimit': '196.5'}, {'value': '94.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '226.0'}]}]}, {'title': 'CD4-CD40-L, Day 60 [N=22;8;7]', 'categories': [{'measurements': [{'value': '6771.5', 'groupId': 'OG000', 'lowerLimit': '3334.0', 'upperLimit': '10235.0'}, {'value': '112.0', 'groupId': 'OG001', 'lowerLimit': '54.5', 'upperLimit': '211.5'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '26.0', 'upperLimit': '213.0'}]}]}, {'title': 'CD4-CD40-L, Day 210 [N=21;8;7]', 'categories': [{'measurements': [{'value': '3953.0', 'groupId': 'OG000', 'lowerLimit': '1477.0', 'upperLimit': '4853.0'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '145.0'}, {'value': '53.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '120.0'}]}]}, {'title': 'CD4-IL-2, Day 0 [N=22;8;7]', 'categories': [{'measurements': [{'value': '104.0', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '160.0'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': '118.0'}, {'value': '120.0', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '267.0'}]}]}, {'title': 'CD4-IL-2, Day 30 [N=22;8;7]', 'categories': [{'measurements': [{'value': '1140.0', 'groupId': 'OG000', 'lowerLimit': '427.0', 'upperLimit': '2141.0'}, {'value': '136.5', 'groupId': 'OG001', 'lowerLimit': '58.0', 'upperLimit': '200.0'}, {'value': '93.0', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '173.0'}]}]}, {'title': 'CD4-IL-2, Day 60 [N=22;9;7]', 'categories': [{'measurements': [{'value': '6640.5', 'groupId': 'OG000', 'lowerLimit': '3213.0', 'upperLimit': '9520.0'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '253.5'}, {'value': '27.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '174.0'}]}]}, {'title': 'CD4-IL-2, Day 210 [N=21;8;7]', 'categories': [{'measurements': [{'value': '4166.0', 'groupId': 'OG000', 'lowerLimit': '1477.0', 'upperLimit': '5347.0'}, {'value': '74.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '127.0'}, {'value': '67.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '120.0'}]}]}, {'title': 'CD40-TNF-α, Day 0 [N=22;8;7]', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '120.0'}, {'value': '106.5', 'groupId': 'OG001', 'lowerLimit': '63.5', 'upperLimit': '154.5'}, {'value': '63.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '240.0'}]}]}, {'title': 'CD4-TNF-α, Day 30 [N=22;8;7]', 'categories': [{'measurements': [{'value': '793.5', 'groupId': 'OG000', 'lowerLimit': '226.0', 'upperLimit': '2093.0'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '65.0'}, {'value': '107.0', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '147.0'}]}]}, {'title': 'CD4-TNF-α, Day 60 [N=22;8;7]', 'categories': [{'measurements': [{'value': '4286.5', 'groupId': 'OG000', 'lowerLimit': '2294.0', 'upperLimit': '6880.0'}, {'value': '38.5', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '78.5'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '226.0'}]}]}, {'title': 'CD4-TNF-α, Day 210 [N=21;8;7]', 'categories': [{'measurements': [{'value': '2632.0', 'groupId': 'OG000', 'lowerLimit': '1560.0', 'upperLimit': '4186.0'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '81.0'}, {'value': '54.0', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '107.0'}]}]}, {'title': 'CD40-IFN-γ, Day 0 [N=22;8;7]', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000', 'lowerLimit': '26.0', 'upperLimit': '212.0'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '113.5'}, {'value': '67.0', 'groupId': 'OG002', 'lowerLimit': '26.0', 'upperLimit': '147.0'}]}]}, {'title': 'CD4-IFN-γ, Day 30 [N=22;8;7]', 'categories': [{'measurements': [{'value': '413.5', 'groupId': 'OG000', 'lowerLimit': '119.0', 'upperLimit': '1373.0'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '82.5', 'upperLimit': '147.5'}, {'value': '106.0', 'groupId': 'OG002', 'lowerLimit': '26.0', 'upperLimit': '199.0'}]}]}, {'title': 'CD4-IFN-γ, Day 60 [N=22;8;7]', 'categories': [{'measurements': [{'value': '1733.5', 'groupId': 'OG000', 'lowerLimit': '440.0', 'upperLimit': '3455.0'}, {'value': '102.5', 'groupId': 'OG001', 'lowerLimit': '53.0', 'upperLimit': '221.0'}, {'value': '26.0', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '79.0'}]}]}, {'title': 'CD4-IFN-γ, Day 210 [N=21;8;7]', 'categories': [{'measurements': [{'value': '667.0', 'groupId': 'OG000', 'lowerLimit': '227.0', 'upperLimit': '2026.0'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '87.0'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '119.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, 30, 60 and 210', 'description': 'Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 \\[IL-2\\] or interferon-gamma \\[IFN-γ\\] or tumour necrosis factor-alpha \\[TNF-α\\]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.\n\nFor CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.', 'unitOfMeasure': 'T cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.'}, {'type': 'SECONDARY', 'title': 'Cell Count of CD4+ T Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'CD4+ T Cells, Day 0', 'categories': [{'measurements': [{'value': '585', 'groupId': 'OG000', 'lowerLimit': '416', 'upperLimit': '651'}, {'value': '437', 'groupId': 'OG001', 'lowerLimit': '318.5', 'upperLimit': '561'}, {'value': '811', 'groupId': 'OG002', 'lowerLimit': '704', 'upperLimit': '1050'}]}]}, {'title': 'CD4+ T Cells, Day 30', 'categories': [{'measurements': [{'value': '566', 'groupId': 'OG000', 'lowerLimit': '465', 'upperLimit': '713'}, {'value': '410.5', 'groupId': 'OG001', 'lowerLimit': '283.5', 'upperLimit': '527.5'}, {'value': '799', 'groupId': 'OG002', 'lowerLimit': '750', 'upperLimit': '978'}]}]}, {'title': 'CD4+ T Cells, Day 60', 'categories': [{'measurements': [{'value': '567', 'groupId': 'OG000', 'lowerLimit': '457', 'upperLimit': '679'}, {'value': '368', 'groupId': 'OG001', 'lowerLimit': '339', 'upperLimit': '572.5'}, {'value': '877', 'groupId': 'OG002', 'lowerLimit': '745', 'upperLimit': '1062'}]}]}, {'title': 'CD 4+ T Cells, Day 210', 'categories': [{'measurements': [{'value': '548.5', 'groupId': 'OG000', 'lowerLimit': '426', 'upperLimit': '680'}, {'value': '433', 'groupId': 'OG001', 'lowerLimit': '377', 'upperLimit': '534'}, {'value': '822', 'groupId': 'OG002', 'lowerLimit': '741', 'upperLimit': '1138'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, 30, 60 and 210', 'description': 'CD4+ T cell counts are defined by values greater than (\\>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.', 'unitOfMeasure': 'T cells/cubic millimeter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Anti-M72 Specific Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'title': 'Anti-M72, Day 0 [N=22;8;7]', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.4'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.4'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '1.4'}]}]}, {'title': 'Anti-M72, Day 30 [N=22;8;7]', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.9'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.4'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '1.4'}]}]}, {'title': 'Anti-M72, Day 60 [N=22;8;7]', 'categories': [{'measurements': [{'value': '282.4', 'groupId': 'OG000', 'lowerLimit': '177.2', 'upperLimit': '450.0'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.4'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '1.4'}]}]}, {'title': 'Anti-M72, Day 210 [N=21;8;7]', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '64.2'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.4'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '1.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0, 30, 60 and 210', 'description': 'Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).', 'unitOfMeasure': 'EL.U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 60 to Day 210', 'description': 'Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'FG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK692342 Group', 'description': 'Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'BG002', 'title': 'Placebo Group', 'description': 'Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '7.43', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '5.61', 'groupId': 'BG001'}, {'value': '41.9', 'spread': '4.67', 'groupId': 'BG002'}, {'value': '40.12', 'spread': '6.54', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], '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': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06-30'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2009-09-03', 'completionDateStruct': {'date': '2009-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2008-06-27', 'dispFirstSubmitQcDate': '2009-09-03', 'resultsFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2008-06-27', 'dispFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-07', 'studyFirstPostDateStruct': {'date': '2008-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Solicited Local Symptoms', 'timeFrame': 'During the 7-day period (Days 0-6) post vaccination following each dose', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'During the 7-day period (Days 0-6) post vaccination following each dose', 'description': 'Assessed solicited general symptoms were fatigue, temperature \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\], gastrointestinal symptoms (gastro) \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 30-day period (Days 0-29) post 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 out-side 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 Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period, from Day 0 up to Day 210', '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 Normal Biochemical and Haematological Levels', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], basophils \\[BAS\\], creatinine \\[CREA\\], eosinophil \\[EOS\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}, {'measure': 'Number of Subjects With Normal Haematological Levels', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were haematocrit \\[Hct\\], haemoglobin \\[Hgb\\], lymphocytes \\[LYM\\], monocytes \\[MON\\], neutrophils \\[NEU\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}, {'measure': 'Number of Subjects With Normal Haematological Levels', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were platelets \\[PLA\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}, {'measure': 'Number of Subjects With Biochemical and Haematological Levels Below Normal', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], basophils \\[BAS\\], creatinine \\[CREA\\], eosinophil \\[EOS\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}, {'measure': 'Number of Subjects With Haematological Levels Below Normal', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were haematocrit \\[Hct\\], haemoglobin \\[Hgb\\], lymphocytes \\[LYM\\], monocytes \\[MON\\], neutrophils \\[NEU\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}, {'measure': 'Number of Subjects With Haematological Levels Below Normal', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were \\[PLA\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}, {'measure': 'Number of Subjects With Biochemical and Haematological Levels Above Normal', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], basophils \\[BAS\\], creatinine \\[CREA\\], eosinophil \\[EOS\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}, {'measure': 'Number of Subjects With Haematological Levels Above Normal', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were haematocrit \\[Hct\\], haemoglobin \\[Hgb\\], lymphocytes \\[LYM\\], monocytes \\[MON\\], neutrophils \\[NEU\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}, {'measure': 'Number of Subjects With Haematological Levels Above Normal', 'timeFrame': 'At Day 0, 7, 30, 37 and 60', 'description': 'Among biochemical and haematological parameters assessed were \\[PLA\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines', 'timeFrame': 'At Day 0, 30, 60 and 210', 'description': 'Among cytokines expressed were interleukin-2 \\[IL-2\\] and/or interferon-gamma \\[IFN-γ\\] and/or tumour necrosis factor-alpha \\[TNF-α\\] and/or cluster of differentiation 40-ligand \\[CD40-L\\]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).'}, {'measure': 'Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule', 'timeFrame': 'At Day 0, 30, 60 and 210', 'description': 'Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 \\[IL-2\\] or interferon-gamma \\[IFN-γ\\] or tumour necrosis factor-alpha \\[TNF-α\\]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.\n\nFor CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.'}, {'measure': 'Cell Count of CD4+ T Cells', 'timeFrame': 'At Day 0, 30, 60 and 210', 'description': 'CD4+ T cell counts are defined by values greater than (\\>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.'}, {'measure': 'Anti-M72 Specific Antibody Concentrations', 'timeFrame': 'At Day 0, 30, 60 and 210', 'description': 'Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).'}, {'measure': 'Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes', 'timeFrame': 'From Day 60 to Day 210', 'description': 'Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.'}]}, 'conditionsModule': {'keywords': ['Tuberculosis vaccine'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '24911353', 'type': 'DERIVED', 'citation': 'Thacher EG, Cavassini M, Audran R, Thierry AC, Bollaerts A, Cohen J, Demoitie MA, Ejigu D, Mettens P, Moris P, Ofori-Anyinam O, Spertini F. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: a phase I/II, randomized trial. AIDS. 2014 Jul 31;28(12):1769-81. doi: 10.1097/QAD.0000000000000343.'}, {'pmid': '24864125', 'type': 'DERIVED', 'citation': 'Roy-Ghanta S, Van der Most R, Li P, Vaughn DW. Responses to A(H1N1)pdm09 influenza vaccines in participants previously vaccinated with seasonal influenza vaccine: a randomized, observer-blind, controlled study. J Infect Dis. 2014 Nov 1;210(9):1419-30. doi: 10.1093/infdis/jiu284. Epub 2014 May 26.'}]}, 'descriptionModule': {'briefSummary': "This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', '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* A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.\n* Written informed consent obtained from the subject prior to any study procedure.\n* Subjects must be HIV-positive and must have:\n\n * received Highly Active Antiretroviral therapy for a minimum of 12 consecutive months prior to screening\n * documented suppressed HIV-1 RNA levels following HAART-treatment.\n * a protocol defined CD4+ T cell count at screening\n* If the subject is female, she must be of non-childbearing potential, or she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of vaccination.\n* Clinically acceptable laboratory values prior to randomisation as determined by the Investigator.\n* No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.\n* No history of extrapulmonary TB.\n* No history of chemotherapy for TB.\n\nExclusion Criteria:\n\n* Any change in antiretroviral drug regimen within 12 weeks prior to screening.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.\n* History of previous administration of experimental Mycobacterium tuberculosis vaccines.\n* History of previous exposure to experimental products containing components of the experimental vaccine.\n* Chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose.\n* Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.\n* Any condition or illness (acute, chronic or history) or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.\n* Planned participation or participation in another experimental protocol during the study period.\n* A family history of congenital or hereditary immunodeficiency. •Any chronic drug therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to be continued during the study period. Vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and SSRIs are allowed.\n* Subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy.\n* History of allergic reactions or anaphylaxis to any vaccine.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* History of chronic alcohol consumption and/or drug abuse which in the Investigator's opinion would put the subject at risk.\n* Pregnant female, lactating female or female planning to become pregnant or stop contraception."}, 'identificationModule': {'nctId': 'NCT00707967', 'briefTitle': 'Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-positive Adults.', 'orgStudyIdInfo': {'id': '111517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Subjects receiving the candidate vaccine', 'interventionNames': ["Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Subjects receiving the adjuvant', 'interventionNames': ['Biological: Control vaccine with the adjuvant system.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C', 'description': 'Subjects receiving physiological saline', 'interventionNames': ['Biological: Control vaccine with physiological saline']}], 'interventions': [{'name': "GSK's candidate Mycobacterium tuberculosis vaccine 692342", 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 2 doses at 0, 1 month', 'armGroupLabels': ['Group A']}, {'name': 'Control vaccine with the adjuvant system.', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 2 doses at 0, 1 month', 'armGroupLabels': ['Group B']}, {'name': 'Control vaccine with physiological saline', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 2 doses at 0, 1 month', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}