Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT05526820
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion rates of the varicella antibody', 'timeFrame': '42 days after immunization of live attenuated varicella vaccine', 'description': 'Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine.'}, {'measure': 'Seroconversion rates of anti-HAV antibody', 'timeFrame': '30 days after full immunization with hepatitis A vaccine', 'description': 'Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.'}], 'secondaryOutcomes': [{'measure': 'Seropositive rates of varicella antibody', 'timeFrame': '42 days after immunization of live attenuated varicella vaccine', 'description': 'Seropositive rates of varicella antibody 42 days after immunization of live attenuated varicella vaccine.'}, {'measure': 'GMT of varicella antibody', 'timeFrame': '42 days after immunization of live attenuated varicella vaccine', 'description': 'GMT of varicella antibody 42 days after immunization of live attenuated varicella vaccine.'}, {'measure': 'GMI of varicella antibody', 'timeFrame': '42 days after immunization of live attenuated varicella vaccine', 'description': 'GMI of varicella antibody 42 days after immunization of live attenuated varicella vaccine.'}, {'measure': 'Seropositive rates of anti-HAV antibody', 'timeFrame': '30 days after full immunization with hepatitis A vaccine', 'description': 'Seropositive rates of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.'}, {'measure': 'GMC of anti-HAV antibody', 'timeFrame': '30 days after full immunization with hepatitis A vaccine', 'description': 'GMC of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.'}, {'measure': 'GMI of anti-HAV antibody', 'timeFrame': '30 days after full immunization with hepatitis A vaccine', 'description': 'GMI of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.'}, {'measure': 'The incidence of adverse events', 'timeFrame': 'within 0-42 days (or 0-30 days) after each dose of vaccine', 'description': 'Incidence of adverse events within 0-42 days (or 0-30 days) after each dose of vaccine.'}, {'measure': 'The incidence of local and systemic solicitation adverse reactions', 'timeFrame': 'Within 0-14 days (or 0-7 days) after each dose of vaccine', 'description': 'The incidence of local and systemic solicitation adverse reactions within 0-14 days (or 0-7 days) after each dose of vaccine.'}, {'measure': 'The incidence of serious adverse events (SAE)', 'timeFrame': 'Within 42 days (or 30 days) after administration of each dose of vaccine', 'description': 'The incidence of serious adverse events (SAE) within 42 days (or 30 days) after administration of each dose of vaccine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Varicella']}, 'referencesModule': {'references': [{'pmid': '36593652', 'type': 'DERIVED', 'citation': 'Sun D, Yu D, Du Z, Jia N, Liu X, Sun J, Xu Q, Sun Z, Luan C, Lv J, Xiong P, Zhang L, Sha X, Gao Y, Kang D. Immunogenicity and safety of a live attenuated varicella vaccine co-administered with inactive hepatitis A vaccine: A phase 4, single-center, randomized, controlled trial. Hum Vaccin Immunother. 2023 Dec 31;19(1):2161789. doi: 10.1080/21645515.2022.2161789. Epub 2023 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.', 'detailedDescription': 'This study is a randomized and controlled phase IV clinical trial in children aged 1 year old (12-15 months).The purpose of this study is to evaluate the immunogenicity and safety of live attenuated varicella vaccine co-administration with inactivated hepatitis A vaccine .The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 450 subjects aged 1 year old (12-15 months) were be enrolled.Subjects were be randomly divided into 2 groups in a ratio of 1:1.Subjects in the combined immunization group received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.Subjects in the Non-combined immunization group received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy child aged 1 year old (12-15 months old);\n* Proven legal identity;\n* The subjects'guardians should be capable of understanding the informed consent form, and such form should be signed prior to enrolment.\n\nExclusion Criteria:\n\n* History of vaccination of varicella vaccine or hepatitis A vaccine.\n* Previous history of varicella infection or hepatitis A infection;\n* History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;\n* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;\n* Thyroid disease or history of thyroidectomy, asplenia,functional asplenia,asplenia or splenectomy resulting from any condition;\n* Suffering from serious chronic diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, etc;\n* Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;\n* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;\n* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before enrollment;\n* Receipt of blood products within the past 3 months;\n* Receipt of other investigational vaccines or drugs within 28 days prior to receiving the investigational vaccine;\n* Receipt of attenuated live vaccines in the past 28 days;\n* Receipt of inactivated or subunit vaccines in the past 7 days;\n* Onset of various acute or chronic diseases within 7 days prior to the study;\n* Armpit temperature in subjects with fever prior to vaccination with the investigational vaccine. 37.4 ℃;\n* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial"}, 'identificationModule': {'nctId': 'NCT05526820', 'briefTitle': 'A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac (Dalian) Vaccine Technology Co., Ltd.'}, 'officialTitle': 'A Randomized, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Inactivated Hepatitis A Vaccine', 'orgStudyIdInfo': {'id': 'PRO-VZV-4001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The combined immunization group', 'description': '225 participants received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.', 'interventionNames': ['Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The Non-combined immunization group', 'description': '225 participants received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.', 'interventionNames': ['Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine']}], 'interventions': [{'name': 'The live attenuated varicella vaccine and the inactivated hepatitis A vaccine', 'type': 'BIOLOGICAL', 'description': 'The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.\n\nThe live attenuated varicella vaccine:live varicella-zoster virus in 0.5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection.\n\nThe inactivated hepatitis A vaccine:250 U inactivated virus in 0.5mL of aluminium hydroxide solution per injection.\n\nAll subjects received hepatitis A vaccine in the upper left arm and varicella vaccine in the upper right arm.', 'armGroupLabels': ['The Non-combined immunization group', 'The combined immunization group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tai’an', 'state': 'Shandong', 'country': 'China', 'facility': 'Feicheng Center for Disease Control and Prevention', 'geoPoint': {'lat': 36.18528, 'lon': 117.12}}], 'overallOfficials': [{'name': 'Dianmin Kang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Provincial Center for Disease Prevention and Control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac (Dalian) Vaccine Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}