Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 11:13 AM
Study NCT ID:
NCT00594958
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2008-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kdubischar-kastner@intercell.com', 'phone': '+43 1 206 20', 'title': 'Senior Manager Clinical Research', 'phoneExt': '0', 'organization': 'Intercell AG'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to Month 6', 'eventGroups': [{'id': 'EG000', 'title': 'IC51 Group A', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches', 'otherNumAtRisk': 212, 'otherNumAffected': 102, 'seriousNumAtRisk': 212, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'IC51 Group B', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches', 'otherNumAtRisk': 213, 'otherNumAffected': 124, 'seriousNumAtRisk': 213, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'IC51 Group C', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches', 'otherNumAtRisk': 211, 'otherNumAffected': 114, 'seriousNumAtRisk': 211, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 34}], 'organSystem': 'General disorders'}, {'term': 'Influenza Like Ilness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 32}], 'organSystem': 'General disorders'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 30}], 'organSystem': 'Infections and infestations'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 10}], 'organSystem': 'Infections and infestations'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 52}], 'organSystem': 'Nervous system disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Acute Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'seriousEvents': [{'term': 'Reflux Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Acute Abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Peritonsillar Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Intracranial Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 213, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'GMT for Anti-JEV Neutralizing Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IC51 Group A', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}, {'id': 'OG001', 'title': 'IC51 Group B', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}, {'id': 'OG002', 'title': 'IC51 Group C', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}], 'classes': [{'categories': [{'measurements': [{'value': '160.71', 'groupId': 'OG000', 'lowerLimit': '140.54', 'upperLimit': '183.76'}, {'value': '272.24', 'groupId': 'OG001', 'lowerLimit': '237.22', 'upperLimit': '312.43'}, {'value': '127.56', 'groupId': 'OG002', 'lowerLimit': '109.51', 'upperLimit': '148.57'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'day 56', 'description': 'Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.', 'unitOfMeasure': 'GMT', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population (observed values)'}, {'type': 'SECONDARY', 'title': 'Safety', 'timeFrame': 'study duration', 'description': 'Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'SCR for Anti-JEC Neutralizing Antibody Titer', 'timeFrame': 'day 56', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IC51 Group A', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}, {'id': 'FG001', 'title': 'IC51 Group B', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}, {'id': 'FG002', 'title': 'IC51 Group C', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '213'}, {'groupId': 'FG002', 'numSubjects': '212'}]}, {'type': 'Randomized and at Least 1 Vaccination', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '213'}, {'groupId': 'FG002', 'numSubjects': '211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '210'}, {'groupId': 'FG002', 'numSubjects': '202'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}, {'value': '636', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'IC51 Group A', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}, {'id': 'BG001', 'title': 'IC51 Group B', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}, {'id': 'BG002', 'title': 'IC51 Group C', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '31.3', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '10.3', 'groupId': 'BG002'}, {'value': '31.3', 'spread': '10.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'numbers based on Safety Population: subjects with at least one vaccination', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '350', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'numbers based on Safety Population: subjects with at least one vaccination', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}, {'value': '636', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population, i.e. subjects who received at least one vaccination'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 639}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2008-01-04', 'resultsFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-05', 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GMT for Anti-JEV Neutralizing Antibody', 'timeFrame': 'day 56', 'description': 'Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'study duration', 'description': 'Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability'}, {'measure': 'SCR for Anti-JEC Neutralizing Antibody Titer', 'timeFrame': 'day 56'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Japanese Encephalitis']}, 'descriptionModule': {'briefSummary': 'The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.', 'detailedDescription': 'This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.\n\n624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test\n\nMain Exclusion Criteria:\n\n* History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence'}, 'identificationModule': {'nctId': 'NCT00594958', 'briefTitle': 'Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51', 'organization': {'class': 'INDUSTRY', 'fullName': 'Valneva Austria GmbH'}, 'officialTitle': 'Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.', 'orgStudyIdInfo': {'id': 'IC51-309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IC51 Group A', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches', 'interventionNames': ['Biological: IC51']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IC51 Group B', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches', 'interventionNames': ['Biological: IC51']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IC51 Group C', 'description': 'IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches', 'interventionNames': ['Biological: IC51']}], 'interventions': [{'name': 'IC51', 'type': 'BIOLOGICAL', 'otherNames': ['Japanese Encephalitis purified inactivated vaccine'], 'description': '6 mcg, intramuscularly \\[i.m.\\], 0.5 mL', 'armGroupLabels': ['IC51 Group A', 'IC51 Group B', 'IC51 Group C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susanne Eder, Mag.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Valneva Austria GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valneva Austria GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}