Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-09 @ 9:11 PM
Study NCT ID:
NCT03460405
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2018-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C057664', 'term': 'Vi polysaccharide vaccine, typhoid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Subject aged 2 - 40 years old:\n\nRandomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.\n\nSubject 6-23 months old:\n\nRandomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subject aged 2 - 40 years old:\n\nRandomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.\n\nSubject aged 6-23 months old:\n\nRandomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2018-03-04', 'studyFirstSubmitQcDate': '2018-03-04', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local reaction and systemic event after vaccination', 'timeFrame': '28 days', 'description': 'Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.'}], 'secondaryOutcomes': [{'measure': 'Adverse events after vaccination', 'timeFrame': 'up to 28 days', 'description': 'Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after 1 dose vaccination.'}, {'measure': 'Serious adverse events after vaccination', 'timeFrame': '28 days', 'description': 'Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination'}, {'measure': 'Geometric Mean Titers (GMT)', 'timeFrame': '28 days', 'description': 'Geometric Mean Titers (GMT) 28 days following immunization'}, {'measure': 'Percentage of subjects with increasing antibody titer >= 4 times', 'timeFrame': '28 days', 'description': 'Percentage of subjects with increasing antibody titer \\>= 4 times in all subjects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues', 'Immunogenicity']}, 'referencesModule': {'references': [{'pmid': '38297337', 'type': 'DERIVED', 'citation': 'Koesnoe S, Medise BE, Rengganis I, Hadinegoro SR, Puspita M, Sari RM, Yang JS, Sahastrabuddhe S, Soedjatmiko, Gunardi H, Sekartini R, Wirahmadi A, Kekalih A, Mukhi S, Satari HI, Bachtiar NS. A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity. Trop Dis Travel Med Vaccines. 2024 Feb 1;10(1):3. doi: 10.1186/s40794-023-00210-z.'}, {'pmid': '33059607', 'type': 'DERIVED', 'citation': 'Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2-11 years: a phase II preliminary report. BMC Pediatr. 2020 Oct 15;20(1):480. doi: 10.1186/s12887-020-02375-4.'}, {'pmid': '32004693', 'type': 'DERIVED', 'citation': 'Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, Sil A, Sahastrabuddhe S, Bachtiar NS. One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine. Int J Infect Dis. 2020 Apr;93:102-107. doi: 10.1016/j.ijid.2020.01.045. Epub 2020 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.', 'detailedDescription': 'To describe the safety of this vaccine following one dose immunization in adults, adolescent, children and infants.\n\nTo assess immunogenicity following one dose of Vi-DT vaccine immunization. To compare the safety and immunogenicity of Vi-DT to Vi polysaccharide vaccine in adults, adolescents, and children groups.\n\nTo compare the safety and immunogenicity of Vi-DT to IPV vaccine in infants groups.\n\nKinetics of Vi-specific IgG antibodies up to 6 months and 1 year after administration of 1 dose of vaccine.\n\nTo evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in infants (≥ 9months -23 months old).\n\nTo evaluate the safety and immunogenicity of MR vaccine co-administered with Vi-DT vaccine in infants (≥ 9months -23 months old).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy\n2. Subjects/Parents have been informed properly regarding the study and signed the informed consent form\n3. Subject/parents/legal guardians will commit themselves to comply with the instructions of the investigator and the schedule of the trial.\n\nExclusion Criteria For adults-adolescent-children:\n\n1. Subject concomitantly enrolled or scheduled to be enrolled in another trial\n2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)\n3. Known history of allergy to any component of the vaccines\n4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection\n5. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).\n6. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives\n7. Pregnancy \\& lactation (Adults)\n8. Individuals who have previously received any vaccines against typhoid fever.\n9. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization.\n10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.\n11. History of substance abuse (Adults).\n12. Subject planning to move from the study area before the end of study period.\n\nExclusion Criteria for infants:\n\n1. Subject concomitantly enrolled or scheduled to be enrolled in another trial\n2. Mother less than 18 years of age at the age of enrollment of the infant\n3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C)\n4. Known history of allergy to any component of the vaccines\n5. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection\n6. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppresant).\n7. Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.\n8. Individuals who have previously received any vaccines against typhoid fever.\n9. Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine.\n10. Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.\n11. Subject planning to move from the study area before the end of study period.'}, 'identificationModule': {'nctId': 'NCT03460405', 'briefTitle': 'Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian Adults, Adolescents, Children and Infants (Phase II)', 'orgStudyIdInfo': {'id': 'Typhoid 0218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VI-DT vaccine (adults,adolescent)', 'description': '1 dose of 0.5 ml Vi-DT vaccine', 'interventionNames': ['Biological: Vi-DT Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vi polysaccharide (adults,adolescent)', 'description': '1 dose of 0.5 ml Vi polysaccharide vaccine', 'interventionNames': ['Biological: Vi Polysaccharide Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'VI-DT vaccine (children)', 'description': '1 dose of 0.5 ml Vi-DT vaccine', 'interventionNames': ['Biological: Vi-DT Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vi polysaccharide vaccine (children)', 'description': '1 dose of 0.5 ml Vi polysaccharide vaccine', 'interventionNames': ['Biological: Vi Polysaccharide Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'VI-DT vaccine (infants)', 'description': '1 dose of 0.5 ml Vi-DT vaccine', 'interventionNames': ['Biological: Vi-DT Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IPV Vaccine (infants)', 'description': '1 dose of 0.5 ml IPV vaccine', 'interventionNames': ['Biological: IPV Vaccine']}], 'interventions': [{'name': 'Vi-DT Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Typhoid Conjugate Vaccine'], 'description': '1 dose of Vi-DT Vaccine', 'armGroupLabels': ['VI-DT vaccine (adults,adolescent)', 'VI-DT vaccine (children)', 'VI-DT vaccine (infants)']}, {'name': 'Vi Polysaccharide Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of Vi Polysaccharide Vaccine', 'armGroupLabels': ['Vi polysaccharide (adults,adolescent)', 'Vi polysaccharide vaccine (children)']}, {'name': 'IPV Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of IPV Vaccine', 'armGroupLabels': ['IPV Vaccine (infants)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Puskesmas Jatinegara', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Puskesmas Senen', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Bernie Endyarni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, University of Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}