Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00249769
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2005-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004672', 'term': 'Encephalitis, Japanese'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008458', 'term': 'Measles Vaccine'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeflores@path.org', 'phone': '(202) 822-0033', 'title': 'Jorge Flores', 'organization': 'PATH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month for serious adverse events and 7 days for non-serious adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 34, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 43, 'seriousNumAtRisk': 236, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 235, 'otherNumAffected': 78, 'seriousNumAtRisk': 235, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Acute bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Tonsillopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atopic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteric fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impetigo contagious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insect bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal parasitism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Maculo-papular lesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-extraction hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-vaccination reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Roseola infantum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 42}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complex Febrile Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'OG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'OG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.1'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '80.1', 'upperLimit': '94.4'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '87.3', 'upperLimit': '95.1'}, {'value': '86.5', 'groupId': 'OG002', 'lowerLimit': '80.6', 'upperLimit': '91.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)', 'description': 'Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol population includes randomized participants who received at least one vaccine dose excluding participants who did not meet the inclusion/exclusion criteria or were found non-compliant to the immunization or blood sampling schedule. The analysis includes participants with valid serology results for measles antibody during retesting.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'OG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'OG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '9.6'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '9.3'}, {'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '10.7'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000', 'lowerLimit': '84.3', 'upperLimit': '96.7'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '85.9', 'upperLimit': '94.1'}, {'value': '90.6', 'groupId': 'OG002', 'lowerLimit': '85.3', 'upperLimit': '94.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)', 'description': 'Seroprotection after LJEV was defined as at least 1:10 dilution as recommended by the World Health Organization (WHO). JE antibody titers were determined by a plaque reduction neutralization test (PRNT).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'OG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'OG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '16.2'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '8.8'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '5.8', 'upperLimit': '8.5'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '318.9', 'groupId': 'OG000', 'lowerLimit': '273.0', 'upperLimit': '372.6'}, {'value': '301.9', 'groupId': 'OG001', 'lowerLimit': '269.0', 'upperLimit': '338.9'}, {'value': '262.5', 'groupId': 'OG002', 'lowerLimit': '222.2', 'upperLimit': '310.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)', 'description': 'Measured using the Enzygnost® Anti-Measles Virus/IgG ELISA assay from Siemens, Marburg, Germany.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population; the analysis includes participants with valid serology results for measles antibody during retesting.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'OG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'OG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '6.5'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '6.1'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '5.3', 'upperLimit': '6.6'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '202.8', 'groupId': 'OG000', 'lowerLimit': '140.5', 'upperLimit': '292.9'}, {'value': '155.0', 'groupId': 'OG001', 'lowerLimit': '123.5', 'upperLimit': '194.5'}, {'value': '139.4', 'groupId': 'OG002', 'lowerLimit': '109.5', 'upperLimit': '177.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)', 'description': 'Assayed by plaque reduction neutralization test (PRNT).', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'OG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'OG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}], 'classes': [{'title': 'Local reactions: any', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Local reactions: mild', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Local reactions: moderate', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Local reactions: severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reactions: any', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reaction: mild', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reaction: moderate', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reaction: severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Fever: any', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Fever: 37.5-38.6°C', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Fever: 38.7-39.9°C', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Fever: ≥ 40°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days after LJEV administration', 'description': 'Local reactions included erythema, pain, swelling, or induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, or fever. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received LJEV'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'OG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'OG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}], 'classes': [{'title': 'Local reactions: any', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Local reactions: mild', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Local reactions: moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Local reactions: severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reactions: any', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reaction: mild', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reaction: moderate', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Systemic reaction: severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Fever: any', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Fever: 37.5-38.6°C', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Fever: 38.7-39.9°C', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Fever: ≥ 40°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days after measles vaccination', 'description': 'Local reactions included erythema, pain, swelling, and induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, and vomiting. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received measles vaccine'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Unsolicited Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'OG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'OG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}], 'classes': [{'title': 'Any Adverse Event', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}, {'title': 'Related adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days post-vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'FG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'FG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '250'}, {'groupId': 'FG002', 'numSubjects': '250'}]}, {'type': 'Received LJEV', 'comment': 'Live Japanese encephalitis vaccine (LJEV)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '236'}, {'groupId': 'FG002', 'numSubjects': '224'}]}, {'type': 'Received Measles Vaccine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '236'}, {'groupId': 'FG002', 'numSubjects': '235'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '235'}, {'groupId': 'FG002', 'numSubjects': '222'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Migration from Study Area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '571', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LJEV Then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.'}, {'id': 'BG001', 'title': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.'}, {'id': 'BG002', 'title': 'MV Then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '0.3', 'groupId': 'BG002'}, {'value': '8.7', 'spread': '0.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '284', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '8.1', 'spread': '1.0', 'groupId': 'BG002'}, {'value': '8.0', 'spread': '1.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '67.6', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '67.7', 'spread': '2.6', 'groupId': 'BG002'}, {'value': '67.4', 'spread': '2.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety population included all participants who received at least 1 vaccination.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2006-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2005-11-03', 'resultsFirstSubmitDate': '2018-09-08', 'studyFirstSubmitQcDate': '2005-11-03', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-25', 'studyFirstPostDateStruct': {'date': '2005-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination', 'timeFrame': 'Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)', 'description': 'Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination', 'timeFrame': 'Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)', 'description': 'Seroprotection after LJEV was defined as at least 1:10 dilution as recommended by the World Health Organization (WHO). JE antibody titers were determined by a plaque reduction neutralization test (PRNT).'}, {'measure': 'Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination', 'timeFrame': 'Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)', 'description': 'Measured using the Enzygnost® Anti-Measles Virus/IgG ELISA assay from Siemens, Marburg, Germany.'}, {'measure': 'Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination', 'timeFrame': 'Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)', 'description': 'Assayed by plaque reduction neutralization test (PRNT).'}, {'measure': 'Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)', 'timeFrame': 'Up to 7 days after LJEV administration', 'description': 'Local reactions included erythema, pain, swelling, or induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, or fever. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.'}, {'measure': 'Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine', 'timeFrame': 'Up to 7 days after measles vaccination', 'description': 'Local reactions included erythema, pain, swelling, and induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, and vomiting. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.'}, {'measure': 'Number of Participants Experiencing Unsolicited Adverse Events (AE)', 'timeFrame': 'Up to 7 days post-vaccination'}]}, 'conditionsModule': {'keywords': ['Japanese Encephalitis', 'Japanese B Encephalitis', 'Japanese B Viral Encephalitis', 'Viral Encephalitis, Japanese B'], 'conditions': ['Encephalitis, Japanese B']}, 'referencesModule': {'references': [{'pmid': '18394765', 'type': 'RESULT', 'citation': 'Gatchalian S, Yao Y, Zhou B, Zhang L, Yoksan S, Kelly K, Neuzil KM, Yaich M, Jacobson J. Comparison of the immunogenicity and safety of measles vaccine administered alone or with live, attenuated Japanese encephalitis SA 14-14-2 vaccine in Philippine infants. Vaccine. 2008 Apr 24;26(18):2234-41. doi: 10.1016/j.vaccine.2008.02.042. Epub 2008 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, it will pave the way for use in routine vaccination programs. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time are protected against these diseases at the same level as those who receive the vaccines at different intervals.', 'detailedDescription': 'Japanese encephalitis is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people-including 700 million children-live in Asian areas at risk for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.\n\nAn effective vaccine has existed since 1941, but has not reached the poorest countries in Asia. During the 60 years that the vaccine has been available, JE has infected an estimated 10.5 million children, resulting in more than 3 million deaths and more than 4 million children living with long-term disabilities. Control of this disease has been limited due to poor disease surveillance, a limited and unstable vaccine supply, lack of guidance and programmatic support for immunization, and limited advocacy.\n\nA successful vaccine should be safe, efficacious, affordable, administered in a single dose, and easily incorporated into the routine Expanded Programmes on Immunization (EPI) programs. This study will help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. If this candidate becomes widely available, it will drastically increase the feasibility of routine JE immunization in Asia, reducing the devastating death and disability caused by this disease. In addition to impacting low-income countries, the vaccine will allow countries that purchase vaccine-such as Thailand, Vietnam, Sri Lanka, and India-to recover health care dollars, improve their present programs, and address other unmet health care needs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Months', 'minimumAge': '8 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is healthy, aged between 8 months (± 2 weeks) at inclusion visit\n* Subject is a full-term infant\n* Subject's parents or legal guardian willing to provide signed informed consent.\n* Children have completed 3 doses each of diphtheria, tetanus, pertussis (DTP) and oral polio vaccine (OPV).\n\nExclusion Criteria:\n\n* History of documented HIV.\n* Known or suspected impairment of immunologic function.\n* History of serious chronic disease\n* Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.\n* Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5°C at the time of inclusion.\n* History of documented suspected encephalitis, encephalopathy, or meningitis\n* History of measles\n* History of thrombocytopenic purpura.\n* Received any JE or measles vaccine prior to enrollment.\n* Received any vaccine, other than the study vaccines, within 2 weeks prior to or scheduled to receive a non-study vaccination during the conduct of this trial.\n* Hypotonic - hyporesponsiveness, after the preceding vaccination.\n* History of seizures, including history of febrile seizures, or any other neurologic disorder.\n* Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy except routine vaccines within 6 weeks of administration of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \\<7 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.\n* Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.\n* Serious adverse event related to the vaccine (i.e., possible, probably, definite)\n* Persistent inconsolable crying (\\>3 hours) observed after a previous dose.\n* Unable to attend the scheduled visits or comply with the study procedures.\n* Enrolled in another clinical trial involving any therapy.\n* Any condition that in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the study objectives."}, 'identificationModule': {'nctId': 'NCT00249769', 'briefTitle': 'Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Assessment of the Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine Given Alone', 'orgStudyIdInfo': {'id': 'JEV01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LJEV then MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.', 'interventionNames': ['Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)', 'Biological: Measles Vaccine (MV)']}, {'type': 'EXPERIMENTAL', 'label': 'LJEV and MV', 'description': 'Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.', 'interventionNames': ['Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)', 'Biological: Measles Vaccine (MV)']}, {'type': 'EXPERIMENTAL', 'label': 'MV then LJEV', 'description': 'Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.', 'interventionNames': ['Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)', 'Biological: Measles Vaccine (MV)']}], 'interventions': [{'name': 'Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)', 'type': 'BIOLOGICAL', 'description': 'Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China.', 'armGroupLabels': ['LJEV and MV', 'LJEV then MV', 'MV then LJEV']}, {'name': 'Measles Vaccine (MV)', 'type': 'BIOLOGICAL', 'description': 'The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO).\n\nSII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979.', 'armGroupLabels': ['LJEV and MV', 'LJEV then MV', 'MV then LJEV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manila', 'country': 'Philippines', 'facility': 'Research Institute for Tropical Medicine', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Salvacion Gatchalian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute for Tropical Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Institute for Tropical Medicine, Manila, Philippines', 'class': 'UNKNOWN'}, {'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}, {'name': 'Mahidol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}