Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT03231605
Status:
UNKNOWN
Last Update Posted:
2017-08-01
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Immunogenicity Study of Two Hepatitis A Vaccines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006506', 'term': 'Hepatitis A'}], 'ancestors': [{'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-30', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-07-24', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.', 'timeFrame': '35-42 days', 'description': 'Collecting serum of subjects before, after vaccination immediately and after 35-42 days, and testing the quantity of antibody. Compared the difference of antibody quantity between two types Hepatitis A Vaccine and the Multiple of antibody based on the time.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '1 month', 'description': 'Observation 30 minutes after vaccination and give guardians feedback forms to record untoward effects, collecting the forms after 1 month when the subjects conduct the third time blood collection.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis A']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM164319.pdf', 'label': 'The reference 6'}, {'url': 'http://med.wanfangdata.com.cn/Paper/Detail?id=PeriodicalPaper_zgswzpxzz200909021', 'label': 'The reference 8'}, {'url': 'http://www.wenkuxiazai.com/doc/c36ab52c58fb770bf78a5529.html', 'label': 'The reference 9'}]}, 'descriptionModule': {'briefSummary': 'Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The healthy children in mental and physical aged between 18-24 months, and the guardians agree and fully understand the protocol.\n* No Hepatitis A disease and contraindication of vaccination\n* No history of Hepatitis A Vaccine\n* The subjects can follow the requirements of experiment project.\n* Do not vaccinate other vaccine in one months.\n* Axillary's temperature≤37℃\n\nExclusion Criteria:\n\n* Having severe diseases.\n* Allergy to the components in Vaccine\n* Immune abnormalities\n* The people who do not agree with the Inclusion Criteria\n* Have a serious chronic disease\n* Any conditions which researcher think will influence the results or the subjects."}, 'identificationModule': {'nctId': 'NCT03231605', 'briefTitle': 'Comparative Immunogenicity Study of Two Hepatitis A Vaccines', 'organization': {'class': 'INDUSTRY', 'fullName': 'China National Biotec Group Company Limited'}, 'officialTitle': 'Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines', 'orgStudyIdInfo': {'id': '91110000100010062X'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd', 'interventionNames': ['Biological: Hepatitis A Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited', 'interventionNames': ['Biological: Hepatitis A Vaccine']}], 'interventions': [{'name': 'Hepatitis A Vaccine', 'type': 'BIOLOGICAL', 'description': 'Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yuncheng', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 35.02306, 'lon': 110.99278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Based on the literature public progress.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Biotec Group Company Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shaanxi Provincial Center for Disease Control and Prevention', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}