Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT00464334
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2007-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Sweden', 'United States']}, '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': 'C493786', 'term': 'ISCOMATRIX'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 years after first dose of vaccine', 'description': 'The Safety Population consisted of all participants who received at least one dose of vaccine.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo to V950/ IMX 0 mcg', 'description': 'Participants receive Placebo to V950/IMX 0 mcg', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo to V950/ IMX 16 mcg', 'description': 'Participants receive Placebo to V950/IMX 16 mcg', 'otherNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'V950 0.5 mcg / IMX 0 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 0 mcg', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'V950 0.5 mcg / IMX 16 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 16 mcg', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'V950 0.5 mcg / IMX 47 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 47 mcg', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'V950 0.5 mcg / IMX 94 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 94 mcg', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'V950 5 mcg / IMX 0 mcg', 'description': 'Participants receive V950 5 mcg/IMX 0 mcg', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'V950 5 mcg / IMX 16 mcg', 'description': 'Participants receive V950 5 mcg/IMX 16 mcg', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'V950 5 mcg / IMX 47 mcg', 'description': 'Participants receive V950 5 mcg/IMX 47 mcg', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'V950 50 mcg / IMX 0 mcg', 'description': 'Participants receive V950 50 mcg/IMX 0 mcg', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'V950 50 mcg / IMX 16 mcg', 'description': 'Participants receive V950 50 mcg/IMX 16 mcg', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to V950/ IMX 0 mcg', 'description': 'Participants receive Placebo to V950/IMX 0 mcg'}, {'id': 'OG001', 'title': 'Placebo to V950/ IMX 16 mcg', 'description': 'Participants receive Placebo to V950/IMX 16 mcg'}, {'id': 'OG002', 'title': 'V950 0.5 mcg / IMX 0 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 0 mcg'}, {'id': 'OG003', 'title': 'V950 0.5 mcg / IMX 16 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 16 mcg'}, {'id': 'OG004', 'title': 'V950 0.5 mcg / IMX 47 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 47 mcg'}, {'id': 'OG005', 'title': 'V950 0.5 mcg / IMX 94 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 94 mcg'}, {'id': 'OG006', 'title': 'V950 5 mcg / IMX 0 mcg', 'description': 'Participants receive V950 5 mcg/IMX 0 mcg'}, {'id': 'OG007', 'title': 'V950 5 mcg / IMX 16 mcg', 'description': 'Participants receive V950 5 mcg/IMX 16 mcg'}, {'id': 'OG008', 'title': 'V950 5 mcg / IMX 47 mcg', 'description': 'Participants receive V950 5 mcg/IMX 47 mcg'}, {'id': 'OG009', 'title': 'V950 50 mcg / IMX 0 mcg', 'description': 'Participants receive V950 50 mcg/IMX 0 mcg'}, {'id': 'OG010', 'title': 'V950 50 mcg / IMX 16 mcg', 'description': 'Participants receive V950 50 mcg/IMX 16 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years after first dose of vaccine', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population consists of all participants who received at least one dose of vaccine.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to V950/ IMX 0 mcg', 'description': 'Participants receive Placebo to V950/IMX 0 mcg'}, {'id': 'OG001', 'title': 'Placebo to V950/ IMX 16 mcg', 'description': 'Participants receive Placebo to V950/IMX 16 mcg'}, {'id': 'OG002', 'title': 'V950 0.5 mcg / IMX 0 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 0 mcg'}, {'id': 'OG003', 'title': 'V950 0.5 mcg / IMX 16 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 16 mcg'}, {'id': 'OG004', 'title': 'V950 0.5 mcg / IMX 47 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 47 mcg'}, {'id': 'OG005', 'title': 'V950 0.5 mcg / IMX 94 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 94 mcg'}, {'id': 'OG006', 'title': 'V950 5 mcg / IMX 0 mcg', 'description': 'Participants receive V950 5 mcg/IMX 0 mcg'}, {'id': 'OG007', 'title': 'V950 5 mcg / IMX 16 mcg', 'description': 'Participants receive V950 5 mcg/IMX 16 mcg'}, {'id': 'OG008', 'title': 'V950 5 mcg / IMX 47 mcg', 'description': 'Participants receive V950 5 mcg/IMX 47 mcg'}, {'id': 'OG009', 'title': 'V950 50 mcg / IMX 0 mcg', 'description': 'Participants receive V950 50 mcg/IMX 0 mcg'}, {'id': 'OG010', 'title': 'V950 50 mcg / IMX 16 mcg', 'description': 'Participants receive V950 50 mcg/IMX 16 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months after first dose of vaccine', 'description': 'This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population consists of all participants who received at least one dose of vaccine.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to V950/IMX 0 mcg', 'description': 'Participants receive Placebo to V950/IMX 0 mcg'}, {'id': 'OG001', 'title': 'Placebo to V950/IMX 16 mcg', 'description': 'Participants receive Placebo to V950/IMX 16 mcg'}, {'id': 'OG002', 'title': 'V950 0.5 mcg/IMX 0 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 0 mcg'}, {'id': 'OG003', 'title': 'V950 0.5 mcg/IMX 16 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 16 mcg'}, {'id': 'OG004', 'title': 'V950 0.5 mcg/IMX 47 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 47 mcg'}, {'id': 'OG005', 'title': 'V950 0.5 mcg/IMX 94 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 94 mcg'}, {'id': 'OG006', 'title': 'V950 5 mcg/IMX 0 mcg', 'description': 'Participants receive V950 5 mcg/IMX 0 mcg'}, {'id': 'OG007', 'title': 'V950 5 mcg/IMX 16 mcg', 'description': 'Participants receive V950 5 mcg/IMX 16 mcg'}, {'id': 'OG008', 'title': 'V950 5 mcg/IMX 47 mcg', 'description': 'Participants receive V950 5 mcg/IMX 47 mcg'}, {'id': 'OG009', 'title': 'V950 50 mcg/IMX 0 mcg', 'description': 'Participants receive V950 50 mcg/IMX 0 mcg'}, {'id': 'OG010', 'title': 'V950 50 mcg/IMX 16 mcg', 'description': 'Participants receive V950 50 mcg/IMX 16 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '363', 'groupId': 'OG000', 'lowerLimit': '161', 'upperLimit': '729'}, {'value': '542.08', 'groupId': 'OG001', 'lowerLimit': '310.16', 'upperLimit': '818.02'}, {'value': '855', 'groupId': 'OG002', 'lowerLimit': '575', 'upperLimit': '1275'}, {'value': '443', 'groupId': 'OG003', 'lowerLimit': '345', 'upperLimit': '560'}, {'value': '990', 'groupId': 'OG004', 'lowerLimit': '990', 'upperLimit': '990'}, {'value': '2208.02', 'groupId': 'OG005', 'lowerLimit': '628.53', 'upperLimit': '12105'}, {'value': '725', 'groupId': 'OG006', 'lowerLimit': '378', 'upperLimit': '1385'}, {'value': '3835', 'groupId': 'OG007', 'lowerLimit': '3835', 'upperLimit': '3835'}, {'value': '1277.38', 'groupId': 'OG008', 'lowerLimit': '604.83', 'upperLimit': '2453.4'}, {'value': '935.55', 'groupId': 'OG010', 'lowerLimit': '447.14', 'upperLimit': '1728.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Month 7', 'description': 'The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.'}, {'type': 'PRIMARY', 'title': 'Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to V950/ IMX 0 mcg', 'description': 'Participants receive Placebo to V950/IMX 0 mcg'}, {'id': 'OG001', 'title': 'Placebo to V950/ IMX 16 mcg', 'description': 'Participants receive Placebo to V950/IMX 16 mcg'}, {'id': 'OG002', 'title': 'V950 0.5 mcg / IMX 0 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 0 mcg'}, {'id': 'OG003', 'title': 'V950 0.5 mcg / IMX 16 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 16 mcg'}, {'id': 'OG004', 'title': 'V950 0.5 mcg / IMX 47 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 47 mcg'}, {'id': 'OG005', 'title': 'V950 0.5 mcg / IMX 94 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 94 mcg'}, {'id': 'OG006', 'title': 'V950 5 mcg / IMX 0 mcg', 'description': 'Participants receive V950 5 mcg/IMX 0 mcg'}, {'id': 'OG007', 'title': 'V950 5 mcg / IMX 16 mcg', 'description': 'Participants receive V950 5 mcg/IMX 16 mcg'}, {'id': 'OG008', 'title': 'V950 5 mcg / IMX 47 mcg', 'description': 'Participants receive V950 5 mcg/IMX 47 mcg'}, {'id': 'OG009', 'title': 'V950 50 mcg / IMX 0 mcg', 'description': 'Participants receive V950 50 mcg/IMX 0 mcg'}, {'id': 'OG010', 'title': 'V950 50 mcg / IMX 16 mcg', 'description': 'Participants receive V950 50 mcg/IMX 16 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '1.16'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '1.06'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.79', 'upperLimit': '1.17'}, {'value': '1.02', 'groupId': 'OG003', 'lowerLimit': '0.82', 'upperLimit': '1.27'}, {'value': '0.15', 'groupId': 'OG004', 'lowerLimit': '0.15', 'upperLimit': '0.15'}, {'value': '2.68', 'groupId': 'OG005', 'lowerLimit': '1.03', 'upperLimit': '8.66'}, {'value': '0.74', 'groupId': 'OG006', 'lowerLimit': '0.18', 'upperLimit': '1.80'}, {'value': '2.27', 'groupId': 'OG007', 'lowerLimit': '2.27', 'upperLimit': '2.27'}, {'value': '1.38', 'groupId': 'OG008', 'lowerLimit': '0.84', 'upperLimit': '2.78'}, {'value': '1.84', 'groupId': 'OG010', 'lowerLimit': '1.29', 'upperLimit': '2.67'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Month 7', 'description': 'The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo to V950/IMX 0 mcg', 'description': 'Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg'}, {'id': 'FG001', 'title': 'Placebo to V950/IMX 16 mcg', 'description': 'Participants receive Placebo to V950/IMX 16 mcg'}, {'id': 'FG002', 'title': 'V950 0.5 mcg/IMX 0 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 0 mcg'}, {'id': 'FG003', 'title': 'V950 0.5 mcg/IMX 16 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 16 mcg'}, {'id': 'FG004', 'title': 'V950 0.5 mcg/IMX 47 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 47 mcg'}, {'id': 'FG005', 'title': 'V950 0.5 mcg/IMX 94 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 94 mcg'}, {'id': 'FG006', 'title': 'V950 5 mcg/IMX 0 mcg', 'description': 'Participants receive V950 5 mcg/IMX 0 mcg'}, {'id': 'FG007', 'title': 'V950 5 mcg/IMX 16 mcg', 'description': 'Participants receive V950 5 mcg/IMX 16 mcg'}, {'id': 'FG008', 'title': 'V950 5 mcg/IMX 47 mcg', 'description': 'Participants receive V950 5 mcg/IMX 47 mcg'}, {'id': 'FG009', 'title': 'V950 50 mcg/IMX 0 mcg', 'description': 'Participants receive V950 50 mcg/IMX 0 mcg'}, {'id': 'FG010', 'title': 'V950 50 mcg/IMX 16 mcg', 'description': 'Participants receive V950 50 mcg/IMX 16 mcg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from 51 sites in Europe, South America and the United States. The primary treatment period was from June 2007 to August 2010, with follow up through January 2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '86', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo to V950/IMX 0 mcg', 'description': 'Participants receive Placebo to V950/IMX 0 mcg'}, {'id': 'BG001', 'title': 'Placebo to V950/IMX 16 mcg', 'description': 'Participants receive Placebo to V950/IMX 16 mcg'}, {'id': 'BG002', 'title': 'V950 0.5 mcg/IMX 0 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 0 mcg'}, {'id': 'BG003', 'title': 'V950 0.5 mcg/IMX 16 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 16 mcg'}, {'id': 'BG004', 'title': 'V950 0.5 mcg/IMX 47 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 47 mcg'}, {'id': 'BG005', 'title': 'V950 0.5 mcg/IMX 94 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 94 mcg'}, {'id': 'BG006', 'title': 'V950 5 mcg/IMX 0 mcg', 'description': 'Participants receive V950 5 mcg/IMX 0 mcg'}, {'id': 'BG007', 'title': 'V950 5 mcg/IMX 16 mcg', 'description': 'Participants receive V950 5 mcg/IMX 16 mcg'}, {'id': 'BG008', 'title': 'V950 5 mcg/IMX 47 mcg', 'description': 'Participants receive V950 5 mcg/IMX 47 mcg'}, {'id': 'BG009', 'title': 'V950 50 mcg/IMX 0 mcg', 'description': 'Participants receive V950 50 mcg/IMX 0 mcg'}, {'id': 'BG010', 'title': 'V950 50 mcg/IMX 16 mcg', 'description': 'Participants receive V950 50 mcg/IMX 16 mcg'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'spread': '10.69', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '76.9', 'spread': '4.39', 'groupId': 'BG002'}, {'value': '73.6', 'spread': '8.07', 'groupId': 'BG003'}, {'value': '76.1', 'spread': '8.01', 'groupId': 'BG004'}, {'value': '73.4', 'spread': '10.89', 'groupId': 'BG005'}, {'value': '72.6', 'spread': '9.26', 'groupId': 'BG006'}, {'value': '72.5', 'spread': '10.10', 'groupId': 'BG007'}, {'value': '81.5', 'spread': '5.48', 'groupId': 'BG008'}, {'value': '70.6', 'spread': '8.38', 'groupId': 'BG009'}, {'value': '75.5', 'spread': '10.04', 'groupId': 'BG010'}, {'value': '74.2', 'spread': '8.85', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '45', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '41', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2007-04-20', 'resultsFirstSubmitDate': '2012-11-19', 'studyFirstSubmitQcDate': '2007-04-20', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-19', 'studyFirstPostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced at Least One Adverse Event', 'timeFrame': 'Up to 4 years after first dose of vaccine', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.'}, {'measure': 'Number of Participants Who Discontinued Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 6 months after first dose of vaccine', 'description': 'This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.'}, {'measure': 'Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7', 'timeFrame': 'Month 7', 'description': 'The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies', 'timeFrame': 'Baseline and Month 7', 'description': 'The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has mild to moderate Alzheimer Disease\n* Women cannot be able to get pregnant\n* Patient has a reliable caregiver, who will attend all visits and answer questions about the patient\n\nExclusion Criteria:\n\n* Patient lives in a nursing home or facility\n* Patient has another neurological or neurodegenerative disorder\n* Patient has a history of stroke\n* Patient uses illicit drugs or has a history of drug/alcohol abuse\n* Patient has received blood or blood derived products within 6 months'}, 'identificationModule': {'nctId': 'NCT00464334', 'briefTitle': 'A Study of V950 in People With Alzheimer Disease (V950-001 AM7)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIX™ in Patients With Alzheimer Disease', 'orgStudyIdInfo': {'id': 'V950-001'}, 'secondaryIdInfos': [{'id': '2007_518', 'type': 'OTHER', 'domain': 'Merck Registration ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo to V950/IMX 0 mcg', 'description': 'Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: ISCOMATRIX™', 'Biological: Placebo to V950']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo to V950/IMX 16 mcg', 'description': 'Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: ISCOMATRIX™', 'Biological: Placebo to V950']}, {'type': 'EXPERIMENTAL', 'label': 'V950 0.5 mcg/IMX 0 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}, {'type': 'EXPERIMENTAL', 'label': 'V950 0.5 mcg/IMX 16 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}, {'type': 'EXPERIMENTAL', 'label': 'V950 0.5 mcg/IMX 47 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}, {'type': 'EXPERIMENTAL', 'label': 'V950 0.5 mcg/IMX 94 mcg', 'description': 'Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}, {'type': 'EXPERIMENTAL', 'label': 'V950 5 mcg/IMX 0 mcg', 'description': 'Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}, {'type': 'EXPERIMENTAL', 'label': 'V950 5 mcg/IMX 16 mcg', 'description': 'Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}, {'type': 'EXPERIMENTAL', 'label': 'V950 5 mcg/IMX 47 mcg', 'description': 'Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}, {'type': 'EXPERIMENTAL', 'label': 'V950 50 mcg/IMX 0 mcg', 'description': 'Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}, {'type': 'EXPERIMENTAL', 'label': 'V950 50 mcg/IMX 16 mcg', 'description': 'Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.', 'interventionNames': ['Biological: V950', 'Biological: ISCOMATRIX™']}], 'interventions': [{'name': 'V950', 'type': 'BIOLOGICAL', 'description': 'V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.', 'armGroupLabels': ['V950 0.5 mcg/IMX 0 mcg', 'V950 0.5 mcg/IMX 16 mcg', 'V950 0.5 mcg/IMX 47 mcg', 'V950 0.5 mcg/IMX 94 mcg', 'V950 5 mcg/IMX 0 mcg', 'V950 5 mcg/IMX 16 mcg', 'V950 5 mcg/IMX 47 mcg', 'V950 50 mcg/IMX 0 mcg', 'V950 50 mcg/IMX 16 mcg']}, {'name': 'ISCOMATRIX™', 'type': 'BIOLOGICAL', 'description': 'ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.', 'armGroupLabels': ['Placebo to V950/IMX 0 mcg', 'Placebo to V950/IMX 16 mcg', 'V950 0.5 mcg/IMX 0 mcg', 'V950 0.5 mcg/IMX 16 mcg', 'V950 0.5 mcg/IMX 47 mcg', 'V950 0.5 mcg/IMX 94 mcg', 'V950 5 mcg/IMX 0 mcg', 'V950 5 mcg/IMX 16 mcg', 'V950 5 mcg/IMX 47 mcg', 'V950 50 mcg/IMX 0 mcg', 'V950 50 mcg/IMX 16 mcg']}, {'name': 'Placebo to V950', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Placebo to V950/IMX 0 mcg', 'Placebo to V950/IMX 16 mcg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}