Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05952505
Status:
UNKNOWN
Last Update Posted:
2023-07-19
First Post:
2023-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D002644', 'term': 'Chickenpox'}, {'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D010309', 'term': 'Parotitis'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-17', 'studyFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2', 'timeFrame': 'on day 28 after vaccination', 'description': 'Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity'}, {'measure': 'non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps', 'timeFrame': 'on day 28 after vaccination', 'description': 'IgG antibodies of measles, rubella, and mumps is an index of immunogenicity'}, {'measure': 'non-inferiority of the seroconversion rate and IgG antibody level against varicella', 'timeFrame': 'on day 28 after vaccination', 'description': 'IgG antibodies of varicella is an index of immunogenicity'}], 'secondaryOutcomes': [{'measure': 'incidence of reported vaccine-related adverse events within 28 days of each immunization.', 'timeFrame': 'from 0 to 28 days after vaccination', 'description': 'adverse events including local and systemic symptoms followng immunization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inactivated SARS-CoV-2 vaccine', 'coadministeration', 'varicella vaccine', 'measles, mumps and rubella combined vaccine'], 'conditions': ['SARS-CoV-2 Infection', 'Varicella', 'Measles', 'Mumps', 'Rubella']}, 'descriptionModule': {'briefSummary': 'Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.\n\nGroup 2 will be immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.\n\nGroup 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.\n\nVaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56. Local and systemic symptoms and serious adverse events following immunzation were collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 4 years old\n* With legal guardian signing the informed consent\n* Able to participate in all planned visits and comply with all research procedures (such as completing diary cards of adverse events and participating visits)\n* With clear vaccination records including no SARS-CoV-2 vaccine history, with 1 varicella vaccine and 2 measles-containing vaccines history\n* the last attenuated vaccine was administered ≥28 days ago, and other vaccines administered ≥14 days ago\n* With an axillary temperature ≤37.5℃ at the time of vaccination\n\nExclusion Criteria:\n\nFirst dose exclusion criteria:\n\n* With SARS-CoV-2 infection in the last 3 months (any of the following conditions shall be met: positive nucleic acid test; positive antigen test; suspected SARS-CoV-2 infection symptoms of subject or close contacts)\n* allergic to any substance of the vaccine or with a severe allergic reactions history of vaccines (such as acute allergic reactions, angioneurotic edema, breathing difficulties, etc.)\n* Suffering uncontrolled epilepsy or progressive nerve system diseases, or with a history of Gribali syndrome\n* With acute illness, severe or acute attack of chronic illness or fever\n* With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs (oral steroids)\n* Received non specific immunoglobulin within 3 months\n* Any situation that researchers thought that might influence the consequence of the clinical trial Second dose exclusion criteria：\n* Occurrence of any serious adverse event that may be related to the previous dose of study vaccine\n* Occurrence of systemic adverse reactions or allergic reactions with a severity level ≥ 3 recognized by researchers after vaccination\n* Any new situations that fit the first dose exclusion criteria\n* Any situation that researchers thought that might influence the consequence of the clinical trial'}, 'identificationModule': {'nctId': 'NCT05952505', 'briefTitle': 'Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Municipal Center for Disease Control and Prevention'}, 'officialTitle': 'Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Varicella Vaccine and Measles, Mumps and Rubella Combined Vaccine in Shanghai, China: A Non-inferiority, Open-label, Randomised, Controlled, Phase 4 Trial', 'orgStudyIdInfo': {'id': 'SH2023-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.', 'interventionNames': ['Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.', 'interventionNames': ['Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.', 'interventionNames': ['Biological: Inactivated SARS-CoV-2 vaccine administered alone']}], 'interventions': [{'name': 'Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine', 'type': 'BIOLOGICAL', 'description': 'Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.', 'armGroupLabels': ['Group 1']}, {'name': 'Inactivated SARS-CoV-2 vaccine coadministered with MMR', 'type': 'BIOLOGICAL', 'description': 'Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.', 'armGroupLabels': ['Group 2']}, {'name': 'Inactivated SARS-CoV-2 vaccine administered alone', 'type': 'BIOLOGICAL', 'description': 'Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '021', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Zhuoying Huang', 'role': 'CONTACT', 'email': 'huangzhuoying@scdc.sh.cn', 'phone': '86-21-62758710'}], 'facility': 'Shanghai Municipal Center for Disease Control and Prevention', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhuoying Huang', 'role': 'CONTACT', 'email': 'huangzhuoying@scdc.sh.cn', 'phone': '86-21-62758710'}], 'overallOfficials': [{'name': 'Zhuoying Huang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Municipal Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Municipal Center for Disease Control and Prevention', 'class': 'OTHER'}, 'collaborators': [{'name': 'China National Biotec Group Company Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'HUANG Zhuoying', 'investigatorAffiliation': 'Shanghai Municipal Center for Disease Control and Prevention'}}}}