Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:01 AM
Study NCT ID:
NCT04612634
Status:
UNKNOWN
Last Update Posted:
2021-02-26
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D022362', 'term': 'Hepatitis A Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D005612', 'term': 'Freeze Drying'}, {'id': 'D015815', 'term': 'Cell Adhesion Molecules'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D015925', 'term': 'Cryopreservation'}, {'id': 'D014021', 'term': 'Tissue Preservation'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D011309', 'term': 'Preservation, Biological'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-01', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Seroconversion rate', 'timeFrame': '4 months', 'description': "Blood samples were collected before and 30 (+ 10) days after immunization. Antibody level and antibody seroconversion rate of HAV-IgG will detect in laboratory. The antibody seroconversion rate of HAV-IgG must maintain the baseline as the other two comparators' products."}], 'secondaryOutcomes': [{'measure': 'Antibody Geometric Mean Titer (GMT)', 'timeFrame': '4 months', 'description': "Antibody GMT will detect in laboratory. The antibody GMT must maintain the baseline as the other two comparators' products."}, {'measure': 'Adverse Events Incidence rate', 'timeFrame': '6 months', 'description': 'Analyse the numbers and rates of participants who suffered from adverse events following immunization.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaccination']}, 'descriptionModule': {'briefSummary': 'Subjects will be recruited and divided into 3 groups:\n\n1. Hepatitis A（Live）Vaccine，Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd\n2. Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd., and\n3. Hepatitis A（Live）Vaccine，Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences.\n\nAfter immunization, the immunogenicity and safety of three different manufacturers will be compared and the data will be analyzed.', 'detailedDescription': 'To evaluate the safety and immunogenicity of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchhun Institute of Biological Products Co., Ltd, we design this randomized, parallel controlled study. 450 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (Research Group 1, 2, and 3), each group assigned 150 subjects respectively.\n\nAll subjects are aged 18-24 months old.\n\n150 subjects from Research Group 1 will be administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchhun Institute of Biological Products Co., Ltd. Blood samples are collected before vaccination and one month (30 days) later.\n\n150 subjects from Research Group 2 will be administrated with one dose of Hepatitis A（Live）Vaccine，Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd. Blood samples are collected before vaccination and one month (30 days) later.\n\n150 subjects from Research Group 3 will be administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. Blood samples are collected before vaccination and one month (30 days) later.\n\nTo evaluate the immunogenicity, we will detect and compare the seroconversion rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. subjects aged from 18 to 24 months old at the date of recruitment;\n2. with informed consent signed by parent(s) or guardians;\n3. parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;\n4. subjects have not been vaccinated with any type of Hepatitis A vaccines;\n5. subjects have no Hepatitis A disease and contraindication of vaccination;\n6. subjects did not receive any vaccines within 14 days;\n7. before joining this trial, subjects must be qualified and passed their medical history and clinical examinations, and axillary's temperature must be ≤37℃.\n\nExclusion Criteria:\n\n1. Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history;\n2. Allergic to any ingredient of vaccine or with allergy history to any vaccine;\n3. Patients with immunodeficiency, in process of cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or in close contact with any family members who has congenital immune diseases;\n4. Receive non-specific immunoglobulin within 1 month before recruitment;\n5. Subjects with acute febrile diseases with body temperature \\> 37.0 ℃ or infectious diseases;\n6. Subjects with a history of thrombocytopenia or other coagulation disorders that may be contraindicated for hypodermic injection;\n7. With known or suspected concurrent diseases include respiratory disease, acute infection or active chronic disease;\n8. With severe cardiovascular diseases (Pulmonary heart disease, Pulmonary edema, hypertension cannot be controlled to normal range by drugs), liver and kidney diseases and diabetic complications;\n9. Various infectious, suppurative or allergic dermatitis;\n10. Other circumstances judged by investigators that are not suitable for this clinical trial."}, 'identificationModule': {'nctId': 'NCT04612634', 'briefTitle': 'Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'China National Biotec Group Company Limited'}, 'officialTitle': 'A Randomized, Parallel Controlled Clinical Trial of the Safety and Immunogenicity of Hepatitis A (Live) Vaccine, Freeze-dried in Children Aged 18-24 Months Old', 'orgStudyIdInfo': {'id': 'JGYM-2020-Ⅳ-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Research Group 1', 'description': '150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd. at the age of 18-24 months old, 0.5 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.', 'interventionNames': ['Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Research Group 2', 'description': '150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd. at the age of 18-24 months old, 0.5 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.', 'interventionNames': ['Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Research Group 3', 'description': '150 subjects are administrated with one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. at the age of 18-24 months old, 1.0 ml each dose, respectively. Blood samples are collected before vaccination and one month (30 days) later.', 'interventionNames': ['Biological: Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS']}], 'interventions': [{'name': 'Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun', 'type': 'BIOLOGICAL', 'description': 'Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose', 'armGroupLabels': ['Research Group 1']}, {'name': 'Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang', 'type': 'BIOLOGICAL', 'description': 'Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.', 'armGroupLabels': ['Research Group 2']}, {'name': 'Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS', 'type': 'BIOLOGICAL', 'description': 'Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml per dose.', 'armGroupLabels': ['Research Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '723399', 'city': 'Hanzhong', 'state': 'Shaanxi', 'country': 'China', 'facility': 'Yangxian Center for Disease Control and Prevention', 'geoPoint': {'lat': 33.07507, 'lon': 107.02214}}, {'zip': '724200', 'city': 'Hanzhong', 'state': 'Shaanxi', 'country': 'China', 'facility': 'Mianxian Center for Disease Control and Prevention', 'geoPoint': {'lat': 33.07507, 'lon': 107.02214}}], 'overallOfficials': [{'name': 'Shaobai Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaanxi Provincial Center for Disease Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Biotec Group Company Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Changchun Institute of Biological Products Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Shaanxi Provincial Center for Disease Control and Prevention', 'class': 'OTHER'}, {'name': 'Mianxian Center for Disease Control and Prevention', 'class': 'UNKNOWN'}, {'name': 'Yangxian Center for Disease Control and Prevention', 'class': 'UNKNOWN'}, {'name': 'Peking University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}