Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-01 @ 9:17 AM
Study NCT ID:
NCT00959192
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2009-08-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603458', 'term': 'vanutide cridificar'}, {'id': 'C078785', 'term': 'saponin QA-21V1'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'ACC-001 3 Micrograms + QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chillblains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Positive Rombergism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lipid metabolism disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebral microhaemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemorrhagic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intercostal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Meralgia paraesthetica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'categories': [{'measurements': [{'value': '1151.5', 'groupId': 'OG000', 'lowerLimit': '165.8', 'upperLimit': '7998.4'}, {'value': '1455.0', 'groupId': 'OG001', 'lowerLimit': '936.2', 'upperLimit': '2261.1'}, {'value': '3903.1', 'groupId': 'OG002', 'lowerLimit': '1151.8', 'upperLimit': '13226.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 28 (n=6,9,7,8)', 'categories': [{'measurements': [{'value': '8216.5', 'groupId': 'OG000', 'lowerLimit': '1550.5', 'upperLimit': '43541.2'}, {'value': '8929.3', 'groupId': 'OG001', 'lowerLimit': '4466.9', 'upperLimit': '17849.8'}, {'value': '7429.5', 'groupId': 'OG002', 'lowerLimit': '3925.7', 'upperLimit': '14060.5'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 30 (n=6,9,7,8)', 'categories': [{'measurements': [{'value': '7218.7', 'groupId': 'OG000', 'lowerLimit': '1438.9', 'upperLimit': '36213.5'}, {'value': '7017.4', 'groupId': 'OG001', 'lowerLimit': '3510.7', 'upperLimit': '14026.7'}, {'value': '6162.2', 'groupId': 'OG002', 'lowerLimit': '3062.2', 'upperLimit': '12400.6'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 40 (n=5,9,8,8)', 'categories': [{'measurements': [{'value': '3136.4', 'groupId': 'OG000', 'lowerLimit': '651.2', 'upperLimit': '15106.7'}, {'value': '2706.5', 'groupId': 'OG001', 'lowerLimit': '1358.1', 'upperLimit': '5393.9'}, {'value': '3615.5', 'groupId': 'OG002', 'lowerLimit': '1145.5', 'upperLimit': '11411.2'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 50 (n=6,8,7,8)', 'categories': [{'measurements': [{'value': '1854.5', 'groupId': 'OG000', 'lowerLimit': '558.3', 'upperLimit': '6159.4'}, {'value': '1255.8', 'groupId': 'OG001', 'lowerLimit': '656.3', 'upperLimit': '2402.9'}, {'value': '1261.4', 'groupId': 'OG002', 'lowerLimit': '699.2', 'upperLimit': '2275.9'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 54 (n=5,8,7,7)', 'categories': [{'measurements': [{'value': '2873.6', 'groupId': 'OG000', 'lowerLimit': '264.8', 'upperLimit': '31178.1'}, {'value': '9636.4', 'groupId': 'OG001', 'lowerLimit': '4558.5', 'upperLimit': '20370.7'}, {'value': '8604.6', 'groupId': 'OG002', 'lowerLimit': '4030.7', 'upperLimit': '18368.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 56 (n=4,8,7,7)', 'categories': [{'measurements': [{'value': '11006.2', 'groupId': 'OG000', 'lowerLimit': '1617.8', 'upperLimit': '74878.3'}, {'value': '7582.4', 'groupId': 'OG001', 'lowerLimit': '3143.9', 'upperLimit': '18286.8'}, {'value': '6201.5', 'groupId': 'OG002', 'lowerLimit': '2921.4', 'upperLimit': '13164.5'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 66 (n=4,8,7,7)', 'categories': [{'measurements': [{'value': '7407.9', 'groupId': 'OG000', 'lowerLimit': '1127.0', 'upperLimit': '48693.5'}, {'value': '3942.5', 'groupId': 'OG001', 'lowerLimit': '1539.4', 'upperLimit': '10096.9'}, {'value': '2452.5', 'groupId': 'OG002', 'lowerLimit': '1442.5', 'upperLimit': '4169.7'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 78 (n=4,8,6,7)', 'categories': [{'measurements': [{'value': '5108.6', 'groupId': 'OG000', 'lowerLimit': '1013.9', 'upperLimit': '25739.1'}, {'value': '2465.3', 'groupId': 'OG001', 'lowerLimit': '961.9', 'upperLimit': '6318.5'}, {'value': '1316.3', 'groupId': 'OG002', 'lowerLimit': '645.0', 'upperLimit': '2686.1'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 91 (n=0,1,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '546.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '389.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 104 (n=0,1,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '414.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '285.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'Geometric mean of anti-a-beta IgG titer from pre-study through Week 104', 'unitOfMeasure': 'Units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.'}, {'type': 'SECONDARY', 'title': 'Anti-a-beta IgM Titer at Specified Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms + QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG002', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG003', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}], 'classes': [{'title': 'Pre-study (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '53.6'}, {'value': '28.2', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '37.4'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '25.0', 'upperLimit': '25.0'}, {'value': '41.5', 'groupId': 'OG003', 'lowerLimit': '21.8', 'upperLimit': '78.8'}]}]}, {'title': 'Week 2 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '347.0'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '31.7', 'upperLimit': '266.6'}, {'value': '53.5', 'groupId': 'OG002', 'lowerLimit': '22.5', 'upperLimit': '127.6'}, {'value': '42.4', 'groupId': 'OG003', 'lowerLimit': '21.6', 'upperLimit': '83.3'}]}]}, {'title': 'Week 4 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '108.5', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '605.6'}, {'value': '141.5', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '481.5'}, {'value': '108.5', 'groupId': 'OG002', 'lowerLimit': '41.0', 'upperLimit': '286.9'}, {'value': '43.7', 'groupId': 'OG003', 'lowerLimit': '21.6', 'upperLimit': '88.3'}]}]}, {'title': 'Week 6 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '953.2', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '9493.1'}, {'value': '2988.4', 'groupId': 'OG001', 'lowerLimit': '879.2', 'upperLimit': '10157.9'}, {'value': '2381.4', 'groupId': 'OG002', 'lowerLimit': '662.7', 'upperLimit': '8556.9'}, {'value': '43.0', 'groupId': 'OG003', 'lowerLimit': '21.6', 'upperLimit': '85.9'}]}]}, {'title': 'Week 8 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '848.6', 'groupId': 'OG000', 'lowerLimit': '85.6', 'upperLimit': '8414.6'}, {'value': '2940.1', 'groupId': 'OG001', 'lowerLimit': '812.5', 'upperLimit': '10639.6'}, {'value': '2776.2', 'groupId': 'OG002', 'lowerLimit': '622.2', 'upperLimit': '12386.2'}, {'value': '46.9', 'groupId': 'OG003', 'lowerLimit': '23.7', 'upperLimit': '92.9'}]}]}, {'title': 'Week 10 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '850.8', 'groupId': 'OG000', 'lowerLimit': '147.5', 'upperLimit': '4907.8'}, {'value': '2432.1', 'groupId': 'OG001', 'lowerLimit': '661.4', 'upperLimit': '8943.5'}, {'value': '2323.9', 'groupId': 'OG002', 'lowerLimit': '482.5', 'upperLimit': '11192.7'}, {'value': '36.1', 'groupId': 'OG003', 'lowerLimit': '19.1', 'upperLimit': '68.2'}]}]}, {'title': 'Week 14 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '1487.6', 'groupId': 'OG000', 'lowerLimit': '288.1', 'upperLimit': '7682.0'}, {'value': '2231.0', 'groupId': 'OG001', 'lowerLimit': '728.6', 'upperLimit': '6831.2'}, {'value': '4438.5', 'groupId': 'OG002', 'lowerLimit': '1000.5', 'upperLimit': '19689.6'}, {'value': '37.6', 'groupId': 'OG003', 'lowerLimit': '19.6', 'upperLimit': '72.3'}]}]}, {'title': 'Week 16 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '1503.2', 'groupId': 'OG000', 'lowerLimit': '254.5', 'upperLimit': '8880.8'}, {'value': '2484.8', 'groupId': 'OG001', 'lowerLimit': '797.6', 'upperLimit': '7740.9'}, {'value': '4590.6', 'groupId': 'OG002', 'lowerLimit': '1041.7', 'upperLimit': '20230.3'}, {'value': '40.5', 'groupId': 'OG003', 'lowerLimit': '18.4', 'upperLimit': '89.5'}]}]}, {'title': 'Week 24 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '898.5', 'groupId': 'OG000', 'lowerLimit': '222.1', 'upperLimit': '3634.1'}, {'value': '1421.8', 'groupId': 'OG001', 'lowerLimit': '442.7', 'upperLimit': '4565.8'}, {'value': '2396.4', 'groupId': 'OG002', 'lowerLimit': '643.2', 'upperLimit': '8928.8'}, {'value': '40.1', 'groupId': 'OG003', 'lowerLimit': '18.4', 'upperLimit': '87.1'}]}]}, {'title': 'Week 28 (n=6,9,7,8)', 'categories': [{'measurements': [{'value': '885.9', 'groupId': 'OG000', 'lowerLimit': '240.0', 'upperLimit': '3270.2'}, {'value': '3395.8', 'groupId': 'OG001', 'lowerLimit': '1356.5', 'upperLimit': '8500.9'}, {'value': '3592.8', 'groupId': 'OG002', 'lowerLimit': '628.7', 'upperLimit': '20531.3'}, {'value': '42.1', 'groupId': 'OG003', 'lowerLimit': '21.3', 'upperLimit': '83.3'}]}]}, {'title': 'Week 30 (n=6,9,7,8)', 'categories': [{'measurements': [{'value': '859.5', 'groupId': 'OG000', 'lowerLimit': '273.2', 'upperLimit': '2704.0'}, {'value': '3729.9', 'groupId': 'OG001', 'lowerLimit': '1286.6', 'upperLimit': '10812.9'}, {'value': '2956.7', 'groupId': 'OG002', 'lowerLimit': '636.6', 'upperLimit': '13732.9'}, {'value': '38.9', 'groupId': 'OG003', 'lowerLimit': '19.4', 'upperLimit': '78.2'}]}]}, {'title': 'Week 40 (n=5,9,8,8)', 'categories': [{'measurements': [{'value': '449.0', 'groupId': 'OG000', 'lowerLimit': '110.4', 'upperLimit': '1825.7'}, {'value': '2480.5', 'groupId': 'OG001', 'lowerLimit': '760.2', 'upperLimit': '8093.8'}, {'value': '1967.3', 'groupId': 'OG002', 'lowerLimit': '421.5', 'upperLimit': '9183.1'}, {'value': '37.8', 'groupId': 'OG003', 'lowerLimit': '19.2', 'upperLimit': '74.4'}]}]}, {'title': 'Week 50 (n=6,8,7,8)', 'categories': [{'measurements': [{'value': '354.2', 'groupId': 'OG000', 'lowerLimit': '75.6', 'upperLimit': '1659.4'}, {'value': '1330.0', 'groupId': 'OG001', 'lowerLimit': '388.5', 'upperLimit': '4553.3'}, {'value': '1326.8', 'groupId': 'OG002', 'lowerLimit': '233.3', 'upperLimit': '7546.2'}, {'value': '39.9', 'groupId': 'OG003', 'lowerLimit': '17.9', 'upperLimit': '88.8'}]}]}, {'title': 'Week 54 (n=5,8,7,7)', 'categories': [{'measurements': [{'value': '680.7', 'groupId': 'OG000', 'lowerLimit': '120.0', 'upperLimit': '3861.3'}, {'value': '2605.4', 'groupId': 'OG001', 'lowerLimit': '862.1', 'upperLimit': '7874.2'}, {'value': '3017.0', 'groupId': 'OG002', 'lowerLimit': '678.8', 'upperLimit': '13408.9'}, {'value': '48.3', 'groupId': 'OG003', 'lowerLimit': '19.2', 'upperLimit': '121.1'}]}]}, {'title': 'Week 56 (n=4,8,7,7)', 'categories': [{'measurements': [{'value': '1768.3', 'groupId': 'OG000', 'lowerLimit': '342.4', 'upperLimit': '9132.4'}, {'value': '2570.6', 'groupId': 'OG001', 'lowerLimit': '794.2', 'upperLimit': '8320.4'}, {'value': '3051.9', 'groupId': 'OG002', 'lowerLimit': '618.2', 'upperLimit': '15066.0'}, {'value': '40.5', 'groupId': 'OG003', 'lowerLimit': '16.4', 'upperLimit': '100.0'}]}]}, {'title': 'Week 66 (n=4,8,7,7)', 'categories': [{'measurements': [{'value': '1213.0', 'groupId': 'OG000', 'lowerLimit': '244.1', 'upperLimit': '6027.2'}, {'value': '1872.7', 'groupId': 'OG001', 'lowerLimit': '523.3', 'upperLimit': '6701.7'}, {'value': '1825.1', 'groupId': 'OG002', 'lowerLimit': '346.2', 'upperLimit': '9621.6'}, {'value': '46.0', 'groupId': 'OG003', 'lowerLimit': '20.2', 'upperLimit': '104.4'}]}]}, {'title': 'Week 78 (n=4,8,6,7)', 'categories': [{'measurements': [{'value': '952.8', 'groupId': 'OG000', 'lowerLimit': '251.0', 'upperLimit': '3617.1'}, {'value': '1650.3', 'groupId': 'OG001', 'lowerLimit': '491.4', 'upperLimit': '5542.5'}, {'value': '844.9', 'groupId': 'OG002', 'lowerLimit': '155.4', 'upperLimit': '4594.7'}, {'value': '48.3', 'groupId': 'OG003', 'lowerLimit': '19.0', 'upperLimit': '122.8'}]}]}, {'title': 'Week 91 (n=0,1,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '219.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '351.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 104 (n=0,1,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '154.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '258.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104', 'unitOfMeasure': 'Units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms + QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG002', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG003', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}], 'classes': [{'title': 'Week 12 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '5.20', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '4.39', 'groupId': 'OG001'}, {'value': '2.93', 'spread': '4.10', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '3.30', 'groupId': 'OG003'}]}]}, {'title': 'Week 26 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '0.39', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '5.41', 'groupId': 'OG001'}, {'value': '3.56', 'spread': '6.74', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': '5.76', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (n=5,9,7,8)', 'categories': [{'measurements': [{'value': '1.87', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '4.82', 'groupId': 'OG001'}, {'value': '5.05', 'spread': '6.68', 'groupId': 'OG002'}, {'value': '1.04', 'spread': '7.01', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (n=4,8,6,7)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '7.08', 'groupId': 'OG001'}, {'value': '5.39', 'spread': '3.66', 'groupId': 'OG002'}, {'value': '2.33', 'spread': '7.78', 'groupId': 'OG003'}]}]}, {'title': 'Week 104 (n=0,1,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG000'}, {'value': '-4.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': '8.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms + QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG002', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG003', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}], 'classes': [{'title': 'Week 12 (n=5,9,7,8)', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '5.1', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '6.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 26 (n=6,9,8,8)', 'categories': [{'measurements': [{'value': '-10.1', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '28.6', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '6.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (n=5,8,6,8)', 'categories': [{'measurements': [{'value': '-11.2', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '5.1', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '9.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (n=4,8,5,6)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '6.9', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '3.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 104 (n=0,1,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG000'}, {'value': '0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': '12.8', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.\n\nA total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms + QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG002', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG003', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}], 'classes': [{'title': 'Week 12 (n=6,9,8,8)', 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.416', 'groupId': 'OG000'}, {'value': '0.275', 'spread': '0.280', 'groupId': 'OG001'}, {'value': '-0.028', 'spread': '0.282', 'groupId': 'OG002'}, {'value': '0.227', 'spread': '0.107', 'groupId': 'OG003'}]}]}, {'title': 'Week 26 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '0.114', 'spread': '0.423', 'groupId': 'OG000'}, {'value': '0.254', 'spread': '0.353', 'groupId': 'OG001'}, {'value': '-0.081', 'spread': '0.530', 'groupId': 'OG002'}, {'value': '0.222', 'spread': '0.308', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (n=5,9,7,8)', 'categories': [{'measurements': [{'value': '0.081', 'spread': '0.288', 'groupId': 'OG000'}, {'value': '0.211', 'spread': '0.285', 'groupId': 'OG001'}, {'value': '-0.109', 'spread': '0.263', 'groupId': 'OG002'}, {'value': '0.213', 'spread': '0.416', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (n=4,8,6,7)', 'categories': [{'measurements': [{'value': '-0.088', 'spread': '0.334', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.494', 'groupId': 'OG001'}, {'value': '-0.120', 'spread': '0.442', 'groupId': 'OG002'}, {'value': '0.246', 'spread': '0.336', 'groupId': 'OG003'}]}]}, {'title': 'Week 104 (n=0,1,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG000'}, {'value': '0.514', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': '-0.559', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': "The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y\\_visit - y\\_base)/SD\\_base, where y\\_visit is a value at a particular time point and y\\_base is the average test score, and SD\\_base is the SD based on all participants' observed baseline scores in the study.", 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms + QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG002', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG003', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}], 'classes': [{'title': 'Week 4 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '2.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '2.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '2.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 (n=6,9,9,8)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 26 (n=6,9,8,8)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 30 (n=6,9,8,8)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '3.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 40 (n=4,9,7,8)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '3.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (n=5,8,7,7)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '2.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (n=4,8,6,7)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '3.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 104 (n=0,1,1,0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACC-001 3 Micrograms + QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'FG001', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'FG002', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'FG003', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Investigator Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Caregiver Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'ACC-001 3 Micrograms + QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'BG001', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'BG002', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'BG003', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.50', 'spread': '8.73', 'groupId': 'BG000'}, {'value': '68.00', 'spread': '10.34', 'groupId': 'BG001'}, {'value': '74.33', 'spread': '6.69', 'groupId': 'BG002'}, {'value': '64.75', 'spread': '7.15', 'groupId': 'BG003'}, {'value': '69.81', 'spread': '8.83', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2009-08-13', 'resultsFirstSubmitDate': '2014-05-09', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-30', 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.", 'timeFrame': 'Baseline up to 24 months', 'description': 'The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.'}, {'measure': 'The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.', 'timeFrame': 'Baseline up to 24 months', 'description': 'The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.\n\nA total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.'}, {'measure': 'The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.', 'timeFrame': 'Baseline up to 24 months', 'description': "The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y\\_visit - y\\_base)/SD\\_base, where y\\_visit is a value at a particular time point and y\\_base is the average test score, and SD\\_base is the SD based on all participants' observed baseline scores in the study."}, {'measure': 'The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.', 'timeFrame': 'Baseline up to 24 months', 'description': 'The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (AEs) by Severity', 'timeFrame': 'Baseline up to 24 months', 'description': "Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)"}, {'measure': 'Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data', 'timeFrame': 'Baseline up to 24 months', 'description': 'Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.'}, {'measure': 'Number of Participants With Abnormalities in Neurological Examination', 'timeFrame': 'Baseline up to 24 months', 'description': 'Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.'}], 'secondaryOutcomes': [{'measure': 'Anti-a-beta IgG Titer at Specified Visits', 'timeFrame': 'Baseline up to 24 months', 'description': 'Geometric mean of anti-a-beta IgG titer from pre-study through Week 104'}, {'measure': 'Anti-a-beta IgM Titer at Specified Visits', 'timeFrame': 'Baseline up to 24 months', 'description': 'Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '25731629', 'type': 'DERIVED', 'citation': "Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54. doi: 10.2174/1567205012666150302154121."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3134K1-2206&StudyName=Safety%2C%20Tolerability%2C%20And%20Immunogenicity%20Study%20Of%20ACC-001%20In%20Japanese%20Subjects%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20Disease', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of mild to moderate Alzheimer's Disease\n* Mini-Mental State Examination (MMSE) 16-26\n\nExclusion Criteria:\n\n* Significant Neurological Disease other than Alzheimer's disease\n* Major psychiatric disorder\n* Clinically significant systemic illness"}, 'identificationModule': {'nctId': 'NCT00959192', 'briefTitle': "Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 Withqs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.", 'orgStudyIdInfo': {'id': '3134K1-2206'}, 'secondaryIdInfos': [{'id': 'B2571009', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACC-001 + QS-21', 'description': 'Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12', 'interventionNames': ['Biological: ACC-001', 'Other: QS-21']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'QS-21', 'description': 'Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12', 'interventionNames': ['Other: QS-21']}], 'interventions': [{'name': 'ACC-001', 'type': 'BIOLOGICAL', 'description': 'IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12', 'armGroupLabels': ['ACC-001 + QS-21']}, {'name': 'QS-21', 'type': 'OTHER', 'description': 'IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12', 'armGroupLabels': ['ACC-001 + QS-21']}, {'name': 'QS-21', 'type': 'OTHER', 'description': 'IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12', 'armGroupLabels': ['QS-21']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530-8480', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Tazuke Kofukai Medical Research Institute Kitano Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '451-8511', 'city': 'Aichi', 'country': 'Japan', 'facility': 'Meitetsu Hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '309-1793', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Ibaraki Prefectural Central Hospital', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '243-8551', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Atsugi Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '252-0380', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Kitasato University East Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '105-8471', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'The Jikei University School of medicine', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '113-8431', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '136-0075', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo Tokyo Koto Geriatric Medical Center', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '158-8531', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'JANSSEN Alzheimer Immunotherapy Research & Development, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}