Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-28 @ 9:41 AM
Study NCT ID:
NCT01198366
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2010-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of AERAS-402 in Healthy Infants
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': {'email': 'blandry@aeras.org', 'phone': '301-547-2919', 'title': 'Product Director', 'organization': 'Aeras'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Finding - Group 1', 'description': 'Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.', 'otherNumAtRisk': 52, 'otherNumAffected': 48, 'seriousNumAtRisk': 52, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Dose Finding - Group 2', 'description': 'Subjects received two doses of AERAS-402 (1.5 x 10\\^10 vp) on study days 0 and 28.', 'otherNumAtRisk': 51, 'otherNumAffected': 47, 'seriousNumAtRisk': 51, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'Dose Finding - Group 3', 'description': 'Subjects received two doses of AERAS-402 (3.0 x 10\\^10 vp) on study days 0 and 28.', 'otherNumAtRisk': 51, 'otherNumAffected': 49, 'seriousNumAtRisk': 51, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Dose Finding - Group 4', 'description': 'Subjects received two doses of AERAS-402 (1.0 x 10\\^11 vp) on study days 0 and 28.', 'otherNumAtRisk': 52, 'otherNumAffected': 52, 'seriousNumAtRisk': 52, 'seriousNumAffected': 18}, {'id': 'EG004', 'title': 'Expanded Safety Phase - Group 5', 'description': 'Subjects received 3 doses of AERAS-402 (1.0 X 10\\^11 vp) on days 0, 28 and 280.', 'otherNumAtRisk': 140, 'otherNumAffected': 136, 'seriousNumAtRisk': 140, 'seriousNumAffected': 40}, {'id': 'EG005', 'title': 'Expanded Safety Phase - Group 5 Placebo', 'description': 'Subjects received 3 doses of placebo (sterile buffer) on days 0, 28 and 280.\n\nPlacebo', 'otherNumAtRisk': 141, 'otherNumAffected': 139, 'seriousNumAtRisk': 141, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 50, 'numAffected': 34}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 48, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tinea capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 47, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 46, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 55, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 55, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 248, 'numAffected': 117}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 214, 'numAffected': 114}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG005', 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{'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 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'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Staphylococcal scalded skin syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Adenoidal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Brain malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 140, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events Collected Per Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}, {'value': '141', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Finding - Group 1', 'description': 'Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.\n\nPlacebo: Sterile buffer'}, {'id': 'OG001', 'title': 'Dose Finding - Group 2', 'description': 'Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.5 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG002', 'title': 'Dose Finding - Group 3', 'description': 'Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 3.0 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG003', 'title': 'Dose Finding - Group 4', 'description': 'Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\\^11 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG004', 'title': 'Expanded Safety Phase - Group 5', 'description': 'Subjects received 3 doses of AERAS-402 (1 X 10\\^11 vp) on days 0, 28 and 280.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG005', 'title': 'Expanded Safety Phase - Group 5 Placebo', 'description': 'Subjects received 3 doses of placebo on days 0, 28 and 280.\n\nPlacebo: Sterile buffer'}], 'classes': [{'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000'}, {'value': '96.1', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '98.6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months post vaccination', 'description': 'Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile', 'unitOfMeasure': 'percentage of subjects with an AE', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Finding - Group 1', 'description': 'Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.\n\nPlacebo: Sterile buffer'}, {'id': 'OG001', 'title': 'Dose Finding - Group 2', 'description': 'Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.5 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG002', 'title': 'Dose Finding - Group 3', 'description': 'Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 3.0 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG003', 'title': 'Dose Finding - Group 4', 'description': 'Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\\^11 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG004', 'title': 'Expanded Safety Phase - Group 5', 'description': 'Subjects received 3 doses of AERAS-402 (1 X 10\\^11 vp) on days 0, 28 and 280.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG005', 'title': 'Expanded Safety Phase - Group 5 Placebo', 'description': 'Subjects received 3 doses of placebo on days 0, 28 and 280.\n\nPlacebo: Sterile buffer'}], 'classes': [{'title': 'Ag85A CD4', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG003', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG004', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.01'}]}]}, {'title': 'Ag85A CD8', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.04'}, {'value': '0.01', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.04'}, {'value': '0.04', 'groupId': 'OG004', 'lowerLimit': '0.01', 'upperLimit': '0.06'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.01'}]}]}, {'title': 'Ag85B CD4', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.03', 'groupId': 'OG003', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.01', 'groupId': 'OG004', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.01'}]}]}, {'title': 'Ag85B CD8', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.08'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.05'}, {'value': '0.04', 'groupId': 'OG003', 'lowerLimit': '0.02', 'upperLimit': '0.07'}, {'value': '0.05', 'groupId': 'OG004', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'TB10.4 CD4', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.01', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.01', 'groupId': 'OG003', 'lowerLimit': '0.01', 'upperLimit': '0.02'}, {'value': '0.01', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.01'}]}]}, {'title': 'TB10.4 CD8', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.01', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.02'}, {'value': '0.01', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.01'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days post last vaccination', 'description': 'To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.', 'unitOfMeasure': 'percentage of Tcell response', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Groups 1-4: Subjects who received both vaccinations as randomized. Group 5: Subjects who received all three study vaccinations as randomized.'}, {'type': 'SECONDARY', 'title': 'Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Finding - Group 1', 'description': 'Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.\n\nPlacebo: Sterile buffer'}, {'id': 'OG001', 'title': 'Dose Finding - Group 2', 'description': 'Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.5 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG002', 'title': 'Dose Finding - Group 3', 'description': 'Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 3.0 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG003', 'title': 'Dose Finding - Group 4', 'description': 'Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\\^11 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG004', 'title': 'Expanded Safety Phase - Group 5', 'description': 'Subjects received 3 doses of AERAS-402 (1 X 10\\^11 vp) on days 0, 28 and 280.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG005', 'title': 'Expanded Safety Phase - Group 5 Placebo', 'description': 'Subjects received 3 doses of placebo on days 0, 28 and 280.\n\nPlacebo: Sterile buffer'}], 'classes': [{'title': 'Ag85A', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '2.50', 'upperLimit': '6.67'}, {'value': '87.92', 'groupId': 'OG003', 'lowerLimit': '74.17', 'upperLimit': '156.67'}, {'value': '98.33', 'groupId': 'OG004', 'lowerLimit': '70.00', 'upperLimit': '151.67'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '3.33'}]}]}, {'title': 'Ag85B', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '5.00'}, {'value': '127.08', 'groupId': 'OG003', 'lowerLimit': '70.83', 'upperLimit': '285.00'}, {'value': '65.00', 'groupId': 'OG004', 'lowerLimit': '51.67', 'upperLimit': '133.33'}, {'value': '0.83', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '5.00'}]}]}, {'title': 'TB10.4', 'categories': [{'measurements': [{'value': '5.42', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '11.67'}, {'value': '26.67', 'groupId': 'OG003', 'lowerLimit': '19.17', 'upperLimit': '49.17'}, {'value': '17.50', 'groupId': 'OG004', 'lowerLimit': '11.67', 'upperLimit': '28.33'}, {'value': '3.33', 'groupId': 'OG005', 'lowerLimit': '1.67', 'upperLimit': '6.67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days post last vaccination', 'description': 'To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings.', 'unitOfMeasure': 'SFU/10^6 PBMC', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Groups 2 and 3).\n\nGroup 5: Subjects who received all three study vaccinations as randomized.'}, {'type': 'SECONDARY', 'title': 'Antigen-specific Antibody Response - Mean Optical Density (Mean OD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Finding - Group 1', 'description': 'Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.\n\nPlacebo: Sterile buffer'}, {'id': 'OG001', 'title': 'Dose Finding - Group 2', 'description': 'Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.5 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG002', 'title': 'Dose Finding - Group 3', 'description': 'Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 3.0 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG003', 'title': 'Dose Finding - Group 4', 'description': 'Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\\^11 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG004', 'title': 'Expanded Safety Phase - Group 5', 'description': 'Subjects received 3 doses of AERAS-402 (1 X 10\\^11 vp) on days 0, 28 and 280.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG005', 'title': 'Expanded Safety Phase - Group 5 Placebo', 'description': 'Subjects received 3 doses of placebo on days 0, 28 and 280.\n\nPlacebo: Sterile buffer'}], 'classes': [{'title': 'Ag85A', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This group was not analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'This group was not analyzed.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.34', 'groupId': 'OG004', 'lowerLimit': '1.08', 'upperLimit': '2.37'}, {'value': '0.20', 'groupId': 'OG005', 'lowerLimit': '0.14', 'upperLimit': '0.30'}]}]}, {'title': 'Ag85B', 'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.38'}, {'value': '2.15', 'groupId': 'OG003', 'lowerLimit': '1.80', 'upperLimit': '2.53'}, {'value': '2.17', 'groupId': 'OG004', 'lowerLimit': '1.95', 'upperLimit': '3.04'}, {'value': '0.37', 'groupId': 'OG005', 'lowerLimit': '0.28', 'upperLimit': '0.72'}]}]}, {'title': 'TB10.4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This group was not analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'This group was not analyzed.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.94', 'groupId': 'OG004', 'lowerLimit': '0.39', 'upperLimit': '1.50'}, {'value': '0.34', 'groupId': 'OG005', 'lowerLimit': '0.25', 'upperLimit': '0.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 day post last vaccination', 'description': 'To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4).', 'unitOfMeasure': 'Optical Density', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Ag85A and TB10.4).\n\nAssays were not done for groups 2 and 3 for any antigen. Group 5: Subjects who received all three study vaccinations as randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}, {'value': '128', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Finding - Group 1', 'description': 'Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.\n\nPlacebo: Sterile buffer'}, {'id': 'OG001', 'title': 'Dose Finding - Group 2', 'description': 'Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.5 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG002', 'title': 'Dose Finding - Group 3', 'description': 'Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 3.0 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG003', 'title': 'Dose Finding - Group 4', 'description': 'Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\\^11 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG004', 'title': 'Expanded Safety Phase - Group 5', 'description': 'Subjects received 3 doses of AERAS-402 (1 X 10\\^11 vp) on days 0, 28 and 280.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'OG005', 'title': 'Expanded Safety Phase - Group 5 Placebo', 'description': 'Subjects received 3 doses of placebo on days 0, 28 and 280.\n\nPlacebo: Sterile buffer'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4.3', 'groupId': 'OG003'}, {'value': '2.4', 'groupId': 'OG004'}, {'value': '4.7', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 24 months post vaccination', 'description': 'To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on \\>= 0.35IU/mL was considered positive for this study.', 'unitOfMeasure': '% converting from QFT neg to pos', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one vaccination and had results at baseline and end of study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Finding - Group 1', 'description': 'Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.\n\nPlacebo: Sterile buffer'}, {'id': 'FG001', 'title': 'Dose Finding - Group 2', 'description': 'Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.5 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'FG002', 'title': 'Dose Finding - Group 3', 'description': 'Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 3.0 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'FG003', 'title': 'Dose Finding - Group 4', 'description': 'Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\\^11 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'FG004', 'title': 'Expanded Safety Phase - Group 5', 'description': 'Subjects received 3 doses of AERAS-402 (1 X 10\\^11 vp) on days 0, 28 and 280.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'FG005', 'title': 'Expanded Safety Phase - Group 5 Placebo', 'description': 'Subjects received 3 doses of placebo on days 0, 28 and 280.\n\nPlacebo: Sterile buffer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '140'}, {'groupId': 'FG005', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '125'}, {'groupId': 'FG005', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}, {'value': '141', 'groupId': 'BG005'}, {'value': '487', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Finding - Group 1', 'description': 'Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.\n\nPlacebo: Sterile buffer'}, {'id': 'BG001', 'title': 'Dose Finding - Group 2', 'description': 'Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.5 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'BG002', 'title': 'Dose Finding - Group 3', 'description': 'Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10\\^10 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 3.0 x 10\\^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'BG003', 'title': 'Dose Finding - Group 4', 'description': 'Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10\\^11 vp) once on Study Day 0 and again on Study Day 28.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'BG004', 'title': 'Expanded Safety Phase - Group 5', 'description': 'Subjects received 3 doses of AERAS-402 (1 X 10\\^11 vp) on days 0, 28 and 280.\n\nAERAS-402 1.0 x 10\\^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.'}, {'id': 'BG005', 'title': 'Expanded Safety Phase - Group 5 Placebo', 'description': 'Subjects received 3 doses of placebo on days 0, 28 and 280.\n\nPlacebo: Sterile buffer'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age at Study Day 0 in Days', 'categories': [{'measurements': [{'value': '145.3', 'spread': '18.15', 'groupId': 'BG000'}, {'value': '144.5', 'spread': '17.83', 'groupId': 'BG001'}, {'value': '138.6', 'spread': '19.45', 'groupId': 'BG002'}, {'value': '149.1', 'spread': '21.44', 'groupId': 'BG003'}, {'value': '145.2', 'spread': '19.98', 'groupId': 'BG004'}, {'value': '150.2', 'spread': '20.22', 'groupId': 'BG005'}, {'value': '146.3', 'spread': '19.97', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': '≥112 days (16 weeks) and ≤182 days (26 weeks) on Study Day 0', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}, {'value': '217', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}, {'value': '84', 'groupId': 'BG005'}, {'value': '270', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '98', 'groupId': 'BG005'}, {'value': '370', 'groupId': 'BG006'}]}]}, {'title': 'Coloured', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '117', 'groupId': 'BG006'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mozambique', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '70', 'groupId': 'BG005'}, {'value': '188', 'groupId': 'BG006'}]}]}, {'title': 'Kenya', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '285', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Two sites in South Africa - Worcester and Soweto. Soweto only participated in Group 5.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 487}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2010-09-07', 'resultsFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-06', 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events Collected Per Subject', 'timeFrame': 'Up to 24 months post vaccination', 'description': 'Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile'}], 'secondaryOutcomes': [{'measure': 'Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects', 'timeFrame': '28 days post last vaccination', 'description': 'To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.'}, {'measure': 'Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay', 'timeFrame': '28 days post last vaccination', 'description': 'To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings.'}, {'measure': 'Antigen-specific Antibody Response - Mean Optical Density (Mean OD)', 'timeFrame': '28 day post last vaccination', 'description': 'To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4).'}, {'measure': 'Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination', 'timeFrame': 'up to 24 months post vaccination', 'description': 'To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on \\>= 0.35IU/mL was considered positive for this study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tuberculosis', 'Vaccine', 'Immunogenicity', 'Prevention of Tuberculosis'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '25936724', 'type': 'BACKGROUND', 'citation': 'Tameris M, Hokey DA, Nduba V, Sacarlal J, Laher F, Kiringa G, Gondo K, Lazarus EM, Gray GE, Nachman S, Mahomed H, Downing K, Abel B, Scriba TJ, McClain JB, Pau MG, Hendriks J, Dheenadhayalan V, Ishmukhamedov S, Luabeya AK, Geldenhuys H, Shepherd B, Blatner G, Cardenas V, Walker R, Hanekom WA, Sadoff J, Douoguih M, Barker L, Hatherill M. A double-blind, randomised, placebo-controlled, dose-finding trial of the novel tuberculosis vaccine AERAS-402, an adenovirus-vectored fusion protein, in healthy, BCG-vaccinated infants. Vaccine. 2015 Jun 9;33(25):2944-54. doi: 10.1016/j.vaccine.2015.03.070. Epub 2015 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.', 'detailedDescription': 'The only currently available tuberculosis vaccine, bacillus Calmette-Guérin (BCG), is estimated to reduce the risk of tuberculosis (TB) in children by up to 70-80%, but protection is incomplete. Efforts to increase TB protection in children include new vaccines for primary immunizations as well as combinations of vaccines given as primary and boosting vaccinations.\n\nAERAS 402 is a live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens (Ag85A, Ag85B and TB10.4). It presents Mtb antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. AERAS-402 appears safe and immunogenic in adults. Since BCG-vaccinated infants are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to infants of at least 16 weeks of age who have already been vaccinated with BCG. This is the first Phase II study of AERAS-402 in infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '182 Days', 'minimumAge': '112 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parent/legal guardian has completed the written informed consent process\n2. Is age greater than or equal to 112 days (16 weeks) and less than or equal 182 days (26 weeks) on Study Day 0\n3. Has general good health, confirmed by medical history and physical examination\n4. Is up to date on all Expanded Program of Immunization (EPI) immunizations for his/her age with a minimum of 14 days between the last EPI vaccination and administration of study vaccine on Study Day 0\n5. Has ability to complete follow-up period of 728 days as required by the protocol\n6. Parent/legal guardian is able and willing to stay in contact with the study site for the duration of the study and to provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study\n7. Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol\n8. Had BCG vaccination ≥ 3 months prior to randomization documented by medical card\n\nExclusion Criteria:\n\n1. Acute illness, evidence of any significant active infection or temperature \\>=37.5°C on the day of randomization\n2. Used immunosuppressive medication within 45 days before entry into the study (inhaled and topical corticosteroids are permitted)\n3. Received immunoglobulin or blood products within 45 days before entry into the study\n4. Ever received any investigational drug therapy or investigational vaccine\n5. History or laboratory evidence of individual immunodeficiency virus (HIV-1) infection\n6. History of allergic disease or reactions to any component of the study vaccine\n7. Previous medical history that may compromise the safety of the participant in the study\n8. Evidence of a new acute illness that may compromise the safety of the participant in the study\n9. Inability to discontinue daily medications during the study\n10. History or evidence of any systemic disease on physical examination or any acute or chronic illness that may interfere with the evaluation of the safety or immunogenicity of the vaccine, e.g., including masses between the leg and abdomen (e.g., inguinal hernia or lymphadenopathy)\n11. History or evidence of active tuberculosis\n12. A positive QuantiFERON®-TB Gold In-Tube test\n13. A household contact with active TB disease'}, 'identificationModule': {'nctId': 'NCT01198366', 'briefTitle': 'Study of AERAS-402 in Healthy Infants', 'organization': {'class': 'OTHER', 'fullName': 'Aeras'}, 'officialTitle': 'A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis', 'orgStudyIdInfo': {'id': 'C-029-402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Dose Finding Gr 1 placebo x 2', 'description': 'Subjects received two doses (x2) of placebo (sterile buffer) on study days 0 and 28.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Finding Gr 2 AERAS-402 (1.5 x 10^10 vp) x2', 'description': 'Subjects received two doses (x2) of AERAS-402 (1.5 x 10\\^10 vp) on study days 0 and 28.', 'interventionNames': ['Biological: AERAS-402 1.5 x 10^10 vp']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Finding Gr 3 AERAS-402 (3.0 x 10^10 vp) x 2', 'description': 'Subjects received two doses (x2) of AERAS-402 (3.0 x 10\\^10 vp) on study days 0 and 28.', 'interventionNames': ['Biological: AERAS-402 3.0 x 10^10 vp']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Finding Gr 4 AERAS-402 (1.0 x 10^11 vp) x 2', 'description': 'Subjects received two doses (x2) of AERAS-402 (1.0 x 10\\^11 vp) on study days 0 and 28.', 'interventionNames': ['Biological: AERAS-402 1.0 x 10^11 vp']}, {'type': 'EXPERIMENTAL', 'label': 'Expanded Safety Phase Gr 5 AERAS-402 (1.0 X 10^11 vp) x 3', 'description': 'Subjects received 3 doses (x3) of AERAS-402 (1.0 X 10\\^11 vp) on days 0, 28 and 280.', 'interventionNames': ['Biological: AERAS-402 1.5 x 10^10 vp']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Expanded Safety Phase Gr 5 Placebo x3', 'description': 'Subjects received 3 doses (x3) of placebo (sterile buffer) on days 0, 28 and 280.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'AERAS-402 1.5 x 10^10 vp', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Dose Finding Gr 2 AERAS-402 (1.5 x 10^10 vp) x2', 'Expanded Safety Phase Gr 5 AERAS-402 (1.0 X 10^11 vp) x 3']}, {'name': 'AERAS-402 3.0 x 10^10 vp', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Dose Finding Gr 3 AERAS-402 (3.0 x 10^10 vp) x 2']}, {'name': 'AERAS-402 1.0 x 10^11 vp', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Dose Finding Gr 4 AERAS-402 (1.0 x 10^11 vp) x 2']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Dose Finding Gr 1 placebo x 2', 'Expanded Safety Phase Gr 5 Placebo x3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boro', 'country': 'Kenya', 'facility': 'Boro Heath Center', 'geoPoint': {'lat': 0.07973, 'lon': 34.24501}}, {'zip': '40100', 'city': 'Kisumu', 'country': 'Kenya', 'facility': 'KEMRI/CDC Research and Public Heath Collaboration', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Siaya', 'country': 'Kenya', 'facility': 'Siaya District Hospital', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}, {'zip': '1929', 'city': 'Manhiça', 'country': 'Mozambique', 'facility': 'CISM: Centro de Investigacao em Saude de Manhica', 'geoPoint': {'lat': -25.40222, 'lon': 32.80722}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Univeristy of Cape Town', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '1864', 'city': 'Soweto', 'country': 'South Africa', 'facility': 'Perinatal HIV Research Unit (PHRU) Chris Hani Baragwanath Hospital', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}, {'zip': '6850', 'city': 'Worcester', 'country': 'South Africa', 'facility': 'SATVI: Worcester', 'geoPoint': {'lat': -33.64651, 'lon': 19.44852}}], 'overallOfficials': [{'name': 'Robert Walker', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aeras'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aeras', 'class': 'OTHER'}, 'collaborators': [{'name': 'European and Developing Countries Clinical Trials Partnership (EDCTP)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}