Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-29 @ 3:13 PM
Study NCT ID:
NCT04051268
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2019-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C057664', 'term': 'Vi polysaccharide vaccine, typhoid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Investigational Product and Active Comparator was masking Number of lot was masking'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects 6 months - 45 years of age: Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine Subjects 46 - 60 years of age: Randomized, observer blind, lot to lot consistency, superiority to Vi polysaccharide vaccine.\n\nSubjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistency'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3071}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-30', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': '28 days', 'description': 'Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.'}], 'secondaryOutcomes': [{'measure': 'Describe antibody response following vaccination', 'timeFrame': '28 days', 'description': 'Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.'}, {'measure': 'Adverse event, solicited or unsolicited', 'timeFrame': '28 days', 'description': 'Number and percentage with at least one adverse event, solicited or unsolicited, within 30 minutes, 72 hours, 7 days, and 28 days after vaccination.'}, {'measure': 'Comparison the safety and immunogenicity', 'timeFrame': '28 days', 'description': 'Comparison of adverse events occuring until 28 days after vaccination between each lot number of Vi-DT (Bio Farma ) vaccine and PQed typhoid conjugate vaccine'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccine', 'Typhoid Conjugate Vaccine'], 'conditions': ['Safety Issues', 'Immunogenicity']}, 'descriptionModule': {'briefSummary': 'Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.', 'detailedDescription': 'Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine.\n\nInvolved participants aged 6 months old to 60 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy.\n* Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form.\n* Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.\n\nExclusion Criteria:\n\n* Subject concomitantly enrolled or scheduled to be enrolled in another trial.\n* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axilary temperature ³ 37.5°C).\n* Known history of allergy to any component of the vaccines.\n* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n* 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 immunosuppressants)\n* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.\n* Pregnancy \\& lactation (Adults).\n* Individuals who have previously received any vaccines against typhoid fever.\n* Subjects already vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except MR (Measles Rubella) vaccine.\n* Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time.\n* Subject planning to move from the study area before the end of study period.'}, 'identificationModule': {'nctId': 'NCT04051268', 'briefTitle': 'Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to Lot Consistency, Non-inferiority to PQed (Prequalified) TCV (Typhoid Conjugate Vaccine)', 'orgStudyIdInfo': {'id': 'Typhoid 0319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vi-DT TCV Batch 1', 'description': '1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1', 'interventionNames': ['Biological: Vi-DT Typhoid Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Vi-DT TCV Batch 2', 'description': '1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2', 'interventionNames': ['Biological: Vi-DT Typhoid Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Vi-DT TCV Batch 3', 'description': '1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3', 'interventionNames': ['Biological: Vi-DT Typhoid Conjugate Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo)', 'description': '1 dose of 0.5 ml of PQed TCV Vaccine', 'interventionNames': ['Biological: PQed Typhoid Conjugate Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vi Polysaccharide Vaccine (subjects 46-60 years old)', 'description': '1 dose of 0.5 ml of Vi Polysaccharide Vaccine', 'interventionNames': ['Biological: Vi Polysaccharide Vaccine']}], 'interventions': [{'name': 'Vi-DT Typhoid Conjugate Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of Investigational Product', 'armGroupLabels': ['Vi-DT TCV Batch 1', 'Vi-DT TCV Batch 2', 'Vi-DT TCV Batch 3']}, {'name': 'PQed Typhoid Conjugate Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of Active Comparator', 'armGroupLabels': ['PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo)']}, {'name': 'Vi Polysaccharide Vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of Active Comparator', 'armGroupLabels': ['Vi Polysaccharide Vaccine (subjects 46-60 years old)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'state': 'Jakart', 'country': 'Indonesia', 'facility': 'Jatinegara Primary Health Care', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Bernie E Medise, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}