Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01396512
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2011-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers
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': 'C000607270', 'term': 'SA-14-14-2 vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'IMOJEV™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of IMOJEV™', 'otherNumAtRisk': 137, 'otherNumAffected': 74, 'seriousNumAtRisk': 137, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'CD.JEVAX™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of CD.JEVAX™', 'otherNumAtRisk': 137, 'otherNumAffected': 69, 'seriousNumAtRisk': 137, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 54, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 44, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Crying Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Appetite Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 40, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hand foot and mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lymph node abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMOJEV™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of IMOJEV™'}, {'id': 'OG001', 'title': 'CD.JEVAX™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of CD.JEVAX™'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '99.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMOJEV™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of IMOJEV™'}, {'id': 'OG001', 'title': 'CD.JEVAX™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of CD.JEVAX™'}], 'classes': [{'title': 'JE-CV PRNT50 antibody titer (pre-vaccination)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '5.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '5.0'}]}]}, {'title': 'JE-CV PRNT50 antibody titer (post-vaccination)', 'categories': [{'measurements': [{'value': '908', 'groupId': 'OG000', 'lowerLimit': '656', 'upperLimit': '1256'}, {'value': '579', 'groupId': 'OG001', 'lowerLimit': '427', 'upperLimit': '784'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).\n\nJE-CV PRNT50 antibody titer \\>10 (1/dil, Day 0)', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMOJEV™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of IMOJEV™'}, {'id': 'OG001', 'title': 'CD.JEVAX™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of CD.JEVAX™'}], 'classes': [{'title': 'JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 28)', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMOJEV™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of IMOJEV™'}, {'id': 'OG001', 'title': 'CD.JEVAX™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of CD.JEVAX™'}], 'classes': [{'title': 'Injection site Pain (N = 137, 137)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Injection site Pain (N = 137, 137)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Injection site Erythema (N = 137, 137)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Injection site Erythema (N = 137, 137)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Injection site Swelling (N = 137, 137)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Injection site Swelling (N = 137, 137)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Fever (N = 134, 136)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Fever (N = 134, 136)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Vomiting (N = 137, 137)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Vomiting (N = 137, 137)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Crying Abnormal (N = 137, 137)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Crying Abnormal (N = 137, 137)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Drowsiness (N = 137, 137)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Drowsiness (N = 137, 137)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Appetite Loss (N = 137, 137)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Appetite Loss (N = 137, 137)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Irritability (N = 137, 137)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Grade 3 Irritability (N = 137, 137)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 14 post-vaccination', 'description': 'Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever \\>39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \\>3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IMOJEV™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of IMOJEV™'}, {'id': 'FG001', 'title': 'CD.JEVAX™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of CD.JEVAX™'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study participants were enrolled from 12 July 2011 to 28 September 2012 at 10 clinic centers in South Korea.', 'preAssignmentDetails': 'A total of 274 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IMOJEV™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of IMOJEV™'}, {'id': 'BG001', 'title': 'CD.JEVAX™ Vaccine Group', 'description': 'Participants age 12 to 24 months received one dose of CD.JEVAX™'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '14.3', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '14.2', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-24', 'studyFirstSubmitDate': '2011-07-14', 'resultsFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2011-07-15', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-24', 'studyFirstPostDateStruct': {'date': '2011-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine', 'timeFrame': 'Day 28 post-vaccination', 'description': 'Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).\n\nJE-CV PRNT50 antibody titer \\>10 (1/dil, Day 0)'}, {'measure': 'Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine', 'timeFrame': 'Day 0 (pre-vaccination) and Day 28 post-vaccination', 'description': 'Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.'}, {'measure': 'Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine', 'timeFrame': 'Day 0 up to Day 14 post-vaccination', 'description': 'Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever \\>39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \\>3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Japanese Encephalitis', 'Japanese Encephalitis Virus Disease', 'IMOJEV™', 'CD.JEVAX™'], 'conditions': ['Japanese Encephalitis', 'Japanese Encephalitis Virus Disease']}, 'referencesModule': {'references': [{'pmid': '25483480', 'type': 'DERIVED', 'citation': 'Kim DS, Houillon G, Jang GC, Cha SH, Choi SH, Lee J, Kim HM, Kim JH, Kang JH, Kim JH, Kim KH, Kim HS, Bang J, Naimi Z, Bosch-Castells V, Boaz M, Bouckenooghe A. A randomized study of the immunogenicity and safety of Japanese encephalitis chimeric virus vaccine (JE-CV) in comparison with SA14-14-2 vaccine in children in the Republic of Korea. Hum Vaccin Immunother. 2014;10(9):2656-63. doi: 10.4161/hv.29743. Epub 2014 Nov 6.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine \\[CD.JEVAX™\\]) after a single dose vaccination to support product registration.\n\nPrimary Objective:\n\n* To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine.\n\nSecondary Objectives:\n\n* To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.\n* To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.', 'detailedDescription': 'All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 12 to 24 months on the day of inclusion\n* In good general health, without significant medical history.\n* Provision of informed consent form signed by at least one parent or other legally acceptable representative.\n* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.\n\nExclusion Criteria:\n\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.\n* Planned participation in another clinical trial during the present trial period.\n* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.\n* Known systemic hypersensitivity to any of IMOJEV™ components or history of a life-threatening reaction to a vaccine containing any of the same substances and vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other components (including Gelatin, kanamycin, and gentamicin).\n* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.\n* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.\n* Previous vaccination against flavivirus disease, including Japanese encephalitis (JE).\n* Administration of any anti-viral within 2 months preceding Visit 01 and up to the 4 weeks following the trial vaccination.\n* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.\n* Planned receipt of any vaccine from the inclusion up to the 4 weeks following the trial vaccination.\n* History of central nervous system disorder or disease, including seizures.\n* Planned receipt of any JE vaccine during the course of the study.\n* History of flavivirus infection (confirmed either clinically, serologically or virologically).\n* Administration of systemic corticosteroids for more than two consecutive weeks within the 4 weeks preceding vaccination.\n* Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment.\n* Thrombocytopenia or bleeding disorder contraindicated for vaccination with same administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.'}, 'identificationModule': {'nctId': 'NCT01396512', 'briefTitle': 'Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of a Single Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) in Comparison With a Single Dose of SA14-14-2 Vaccine (CD.JEVAX™, Chengdu Institute of Biological Products, China) Administered in Healthy Toddlers in South-Korea', 'orgStudyIdInfo': {'id': 'JEC12'}, 'secondaryIdInfos': [{'id': 'U1111-1117-7378', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMOJEV™ Vaccine Group', 'description': 'Participants will receive a single dose of the Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV™) on Day 0.', 'interventionNames': ['Biological: Live attenuated Japanese encephalitis chimeric virus vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CD.JEVAX ™ Vaccine Group', 'description': 'Participants will receive a single dose of the Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine), CD.JEVAX™ on Day 0', 'interventionNames': ['Biological: Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)']}], 'interventions': [{'name': 'Live attenuated Japanese encephalitis chimeric virus vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['IMOJEV™'], 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['IMOJEV™ Vaccine Group']}, {'name': 'Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)', 'type': 'BIOLOGICAL', 'otherNames': ['CD.JEVAX™'], 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['CD.JEVAX ™ Vaccine Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goyang', 'country': 'South Korea', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Incheon', 'country': 'South Korea', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seongnam', 'country': 'South Korea', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Wŏnju', 'country': 'South Korea', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur SA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}