Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT00314132
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2006-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D004672', 'term': 'Encephalitis, Japanese'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022321', 'term': 'Japanese Encephalitis Vaccines'}, {'id': 'C445780', 'term': 'ChimeriVax'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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 events data were collected from Day 0 to Month 6 post vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received a single injection of placebo on Day 0.', 'otherNumAtRisk': 403, 'otherNumAffected': 124, 'seriousNumAtRisk': 403, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'ChimeriVax™-JE 4 log10 PFU Vaccine', 'description': 'Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.', 'otherNumAtRisk': 1601, 'otherNumAffected': 597, 'seriousNumAtRisk': 1601, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 42, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 251, 'numAffected': 183}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 50, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 228, 'numAffected': 164}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 33, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 219, 'numAffected': 138}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 38, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 193, 'numAffected': 147}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Feeling Hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 55, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 281, 'numAffected': 193}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 51, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 279, 'numAffected': 199}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 150, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 664, 'numAffected': 383}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 104, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 561, 'numAffected': 352}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 44, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 259, 'numAffected': 179}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 251, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 1253, 'numAffected': 597}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 33, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 122, 'numAffected': 89}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 141, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 699, 'numAffected': 365}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'seriousEvents': [{'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Streptococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Fallopian Tube Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1601, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '1601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'All subjects received a single injection of placebo on Day 0.'}, {'id': 'OG001', 'title': 'ChimeriVax™-JE 4 log10 PFU Vaccine', 'description': 'All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Pain', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}, {'title': 'Feeling Hot', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Pruritus', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal Pain', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Pharyngolaryngeal Pain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to 30 days post-vaccination', 'description': 'Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '1601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a single injection of placebo on Day 0.'}, {'id': 'OG001', 'title': 'ChimeriVax™-JE 4 log10 PFU Vaccine', 'description': 'Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.'}], 'classes': [{'title': 'Injection Site Pain', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Pruritus', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Hemorrhage', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Swelling', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Reaction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Rash', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Induration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Joint Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Paresthesia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Stinging', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Warmth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to 30 days post-vaccination', 'description': 'Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.\n\nTreatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received a single injection of placebo on Day 0.'}, {'id': 'FG001', 'title': 'ChimeriVax™-JE 4 log10 PFU Vaccine', 'description': 'Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '1601'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '1583'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled and vaccinated from 10 October 2005 to 30 March 2006 at 6 clinical centers in Australia and 16 clinical centers in the US.', 'preAssignmentDetails': 'A total of 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '1601', 'groupId': 'BG001'}, {'value': '2004', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a single injection of placebo on Day 0.'}, {'id': 'BG001', 'title': 'ChimeriVax™-JE 4 log10 PFU Vaccine', 'description': 'Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '1601', 'groupId': 'BG001'}, {'value': '2004', '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': '34.8', 'spread': '14.12', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '14.25', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '14.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '721', 'groupId': 'BG001'}, {'value': '886', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '880', 'groupId': 'BG001'}, {'value': '1118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '1201', 'groupId': 'BG001'}, {'value': '1464', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '400', 'groupId': 'BG001'}, {'value': '540', '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': 2004}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2006-04-11', 'resultsFirstSubmitDate': '2012-11-06', 'studyFirstSubmitQcDate': '2006-04-11', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-06', 'studyFirstPostDateStruct': {'date': '2006-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo', 'timeFrame': 'Day 0 up to 30 days post-vaccination', 'description': 'Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.'}, {'measure': 'Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo', 'timeFrame': 'Day 0 up to 30 days post-vaccination', 'description': 'Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.\n\nTreatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Japanese Encephalitis', 'Encephalitis virus', 'ChimeriVax™-JE Vaccine'], 'conditions': ['Encephalitis', 'Japanese Encephalitis']}, 'referencesModule': {'references': [{'pmid': '20934459', 'type': 'DERIVED', 'citation': 'Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent obtained from the subject.\n* Aged 18 years or above at screening.\n* In good general health\n* Subject available for the study duration\n* For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.\n\nExclusion Criteria:\n\n* A history of vaccination against or infection with JE.\n* Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.\n* History of thymoma, thymic surgery (removal) or myasthenia gravis.\n* Clinically significant abnormalities on laboratory assessment\n* Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).\n* Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.\n* Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.\n* Physical examination indicating any clinically significant medical condition.\n* Oral temperature \\>38°C (100.4°F) or acute illness within 3 days prior to inoculation.\n* Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.\n* Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.\n* Lactation or intended pregnancy in female subjects.\n* Excessive alcohol consumption, drug abuse, significant psychiatric illness.\n* A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).\n* Participation in another clinical study within 30 days of the screening visit for this study.\n* Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.\n* Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study."}, 'identificationModule': {'nctId': 'NCT00314132', 'briefTitle': 'Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)', 'orgStudyIdInfo': {'id': 'H-040-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'All subjects received a single injection of placebo on Day 0.', 'interventionNames': ['Biological: 0.9% Saline']}, {'type': 'EXPERIMENTAL', 'label': 'ChimeriVax™ JE 4 log10 PFU Vaccine', 'description': 'All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.', 'interventionNames': ['Biological: ChimeriVax-JE, Japanese Encephalitis vaccine']}], 'interventions': [{'name': 'ChimeriVax-JE, Japanese Encephalitis vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['ChimeriVax™'], 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['ChimeriVax™ JE 4 log10 PFU Vaccine']}, {'name': '0.9% Saline', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92505', 'city': 'Burbank', 'state': 'California', 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'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '48152', 'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}, {'zip': '65802', 'city': 'Sprnigfield', 'state': 'Missouri', 'country': 'United States'}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27109', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': 'NSW 2010', 'city': 'Darlinghurst', 'country': 'Australia', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': 'QLD 4051', 'city': 'Enoggera', 'country': 'Australia', 'geoPoint': {'lat': -27.42832, 'lon': 152.97467}}, {'zip': 'VIC 3081', 'city': 'Heidelbeg West', 'country': 'Australia'}, {'zip': 'QLD 4021', 'city': 'Kippa-Ring', 'country': 'Australia', 'geoPoint': {'lat': -27.22586, 'lon': 153.0835}}, {'zip': 'VIC 3082', 'city': 'Mill Park', 'country': 'Australia', 'geoPoint': {'lat': -37.66667, 'lon': 145.06667}}, {'zip': 'SA 5056', 'city': 'Toorak Gardens', 'country': 'Australia', 'geoPoint': {'lat': -34.93478, 'lon': 138.63639}}], 'overallOfficials': [{'name': 'Steven G Hull, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vince and Associates Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}