Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT02526550
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2015-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D006505', 'term': 'Hepatitis'}], '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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022362', 'term': 'Hepatitis A Vaccines'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kulkanya.cho@mahidol.ac.th', 'phone': '662 4195695', 'title': 'Prof.Kulkanya Chokephaibulkit', 'organization': 'Siriraj Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '28 days following vaccination', 'description': "Patients' parents/guardians were provided with rulers, digital thermometers, and diary cards to record daily temperature and any solicited local injection site reactions (pain, redness, and swelling) and general symptoms (fever, abnormal crying/irritability, drowsiness, loss of appetite and skin rash) during the 28-day period following each study vaccination. The occurrence of unsolicited (i.e. spontaneously reported) adverse events were recorded for up to 28 days following vaccination.", 'eventGroups': [{'id': 'EG000', 'title': 'Imojev', 'description': 'Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh\n\nLive attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh\n\nInactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh', 'otherNumAtRisk': 49, 'otherNumAffected': 31, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Immediate reactions', 'notes': 'Any reactions occurring within 30 minutes following vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Solicited local reactions', 'notes': 'Solicited injection site reactions including pain, redness, swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Solicited systemic reactions', 'notes': 'Solicited systemic reactions including fever, crying/irritability, drowsiness, low appetite, skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 25, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Unsolicited adverse events', 'notes': "Unsolicited adverse events are the spontaneously reported adverse events by patients or patients' parents/guardians", 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 34, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imojev', 'description': 'Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh\n\nLive attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh\n\nInactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '9144', 'groupId': 'OG000', 'lowerLimit': '7365', 'upperLimit': '11353'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (Baseline) 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).', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imojev', 'description': 'Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh\n\nLive attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh\n\nInactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (Baseline) 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': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imojev', 'description': 'Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh\n\nLive attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh\n\nInactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh'}], 'classes': [{'title': 'Immediate reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Injection site redness', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Crying/Irritability', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'Low Appetite', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Skin Rash', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}]}]}, {'title': 'Unsolicited adverse events', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days post booster vaccination', 'description': 'Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Imojev', 'description': 'Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh\n\nLive attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh\n\nInactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "This phase IV study was conducted between 01 June 2014 and 04 July 2014 in accordance with ICH GCP. The study was approved by the Siriraj IRB. Written Informed Consent was obtained from all participants' parents or legal guardians before study entry."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Imojev', 'description': 'Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh\n\nLive attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh\n\nInactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Thailand', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2015-08-09', 'resultsFirstSubmitDate': '2016-01-12', 'studyFirstSubmitQcDate': '2015-08-17', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-13', 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination', 'timeFrame': 'Day 0 (Baseline) 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).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination', 'timeFrame': 'Day 0 (Baseline) 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': 'Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™', 'timeFrame': 'Up to 28 days post booster vaccination', 'description': 'Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Live attenuated Japanese Encephalitis vaccine', 'IMOJEV', 'CD.JEVAX', 'Booster', 'Thai children', 'Immunogenicity', 'Safety', 'Interchangeability', 'Hepatitis A vaccine', 'Vaccination or Other Immunization Procedure'], 'conditions': ['Encephalitis']}, 'referencesModule': {'references': [{'pmid': '27846060', 'type': 'DERIVED', 'citation': 'Sricharoenchai S, Lapphra K, Chuenkitmongkol S, Phongsamart W, Bouckenooghe A, Wittawatmongkol O, Rungmaitree S, Chokephaibulkit K. Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine as a Booster Dose After Primary Vaccination With Live Attenuated SA14-14-2 Vaccine: A Phase IV Study in Thai Children. Pediatr Infect Dis J. 2017 Feb;36(2):e45-e47. doi: 10.1097/INF.0000000000001395.'}]}, 'descriptionModule': {'briefSummary': 'This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to \\<5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.', 'detailedDescription': 'The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1 to \\<5 years on the day of inclusion\n* History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment\n* In good general health at the time of inclusion\n* Provision of informed consent by the parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n* Receipt of blood or blood products in the past 3 months\n* Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)\n* Previous receipt of 2 doses of any vaccine against JE virus\n* Known hypersensitivity to any of the vaccine components\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination\n* Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination'}, 'identificationModule': {'nctId': 'NCT02526550', 'briefTitle': 'Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children', 'orgStudyIdInfo': {'id': 'JEC26-EXT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imojev', 'description': 'Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh', 'interventionNames': ['Biological: Live attenuated chimeric Japanese Encephalitis vaccine', 'Biological: Inactivated Hepatitis A vaccine']}], 'interventions': [{'name': 'Live attenuated chimeric Japanese Encephalitis vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Imojev'], 'description': '0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh', 'armGroupLabels': ['Imojev']}, {'name': 'Inactivated Hepatitis A vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Havrix'], 'description': '0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh', 'armGroupLabels': ['Imojev']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kulkanya Chokephaibulkit, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The submission of study review and results to a peer-review journal is ongoing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kulkanya Chokephaibulkit', 'investigatorAffiliation': 'Siriraj Hospital'}}}}