Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05870618
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2023-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-05-12', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion rates of the vaccination', 'timeFrame': '28-42 days after the dose of DTaP or DT', 'description': 'Defined as any positive antibody response against pertussis，diphtheria，tetanus in children who were seronegative prior to the vaccination, or at least a fourfold increase in antibody levels against pertussis for children who had pre-existing positive antibodies'}, {'measure': 'Seropositive rates after the vaccination', 'timeFrame': '28-42 days after the dose of DTaP or DT', 'description': 'The percentage of participants with positive antibody against pertussis，diphtheria and tetanus'}], 'secondaryOutcomes': [{'measure': 'Safety of the DTaP or DT vaccine immunization', 'timeFrame': '28 days after the vaccination', 'description': 'The occurrence of adverse events for vaccination administered at age 6 using DTaP or DT'}, {'measure': 'Geometric mean antibody concentrations before the vaccination', 'timeFrame': 'before the dose of DTaP or DT', 'description': 'The GMC against pertussis，diphtheria and tetanus'}, {'measure': 'Geometric mean antibody concentrations after the vaccination', 'timeFrame': '28-42 days after the dose of DTaP or DT', 'description': 'The GMC against pertussis，diphtheria and tetanus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunogenicity，safety，DTaP，DT'], 'conditions': ['Vaccine Reaction']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.', 'detailedDescription': 'A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years. DTaP and DT are produced by Wuhan Biological Products Co., LTD. Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28\\~42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '84 Months', 'minimumAge': '72 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants aged ≥ 6 on the day of enrollment;\n2. Informed consent should be signed and dated by the participants;\n3. The participant's legal guardian is able to attend all planned follow-up visits and comply with all study procedures;\n4. The participants have received 4 doses of acellular TDap vaccine and have not received any immunization agents related to diphtheria, tetanus, and pertussis in the past 3 years;\n5. The participant has no diease history of pertussis, diphtheria or tetanus;\n6. ≥ 14 days interval between the last vaccination;\n7. Body temperature was ≤37.3℃.\n\nExclusion Criteria:\n\n1. Being allergic to any component of vaccines ；\n2. A history of severe allergic reactions to any vaccine (for example acute allergic reaction, angioneurotic edema, dyspnea, etc）；\n3. Having a history or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy and other progressive neurological diseases;\n4. Participants are suffering from immunodeficiency, receiving immunosuppressant therapy (oral steroid hormones) during treatment for malignancy, or having low immunity due to HIV, or having congenital immune disorders in close family members;\n5. Injection of non-specific immunoglobulin within 1 month before enrollment;\n6. Participants are suffering from acute febrile diseases and infectious diseases;\n7. A history of clearly diagnosed thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection;\n8. Participants with severe chronic diseases or acute episodes of chronic diseases;\n9. Participants with infectious, suppurative and allergic skin diseases;\n10. Other Participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies."}, 'identificationModule': {'nctId': 'NCT05870618', 'acronym': 'DTaP/DT', 'briefTitle': 'Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zhejiang Provincial Center for Disease Control and Prevention'}, 'officialTitle': 'Immunogenicity and Safety of Adsorbed Diphtheria, Tetanus, Acellular Pertussis Combined Vaccine or Adsorbed Diphtheria Tetanus Combined Vaccine in 6 Years Old Children：a Randomized, Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'DTaP/DT-2023-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Group with DTap vaccination produced by Wuhan Institute of Biological Products Co., Ltd', 'interventionNames': ['Biological: vaccinate with DTap']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group with DT vaccination', 'interventionNames': ['Biological: vaccinate with DT']}], 'interventions': [{'name': 'vaccinate with DTap', 'type': 'BIOLOGICAL', 'description': 'vaccinate with DTap', 'armGroupLabels': ['Group A']}, {'name': 'vaccinate with DT', 'type': 'BIOLOGICAL', 'description': 'vaccinate with DT', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '322000', 'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Shuying Luo', 'role': 'CONTACT', 'email': '1628865370@qq.com', 'phone': '+86 579 89938150'}], 'facility': 'Yiwu Center for Disease Control and Prevention', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'zip': '324400', 'city': 'Quzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Zhongbing Chen', 'role': 'CONTACT', 'email': '284060893@qq.com', 'phone': '+86 570 7770012'}], 'facility': 'longyou Center for Disease Control and Prevention', 'geoPoint': {'lat': 28.95944, 'lon': 118.86861}}], 'centralContacts': [{'name': 'Hanqing He', 'role': 'CONTACT', 'email': 'hanqinghe@cdc.zj.cn', 'phone': '+86 571 87115170'}, {'name': 'Xuewen Tang', 'role': 'CONTACT', 'email': 'xwtang@cdc.zj.cn', 'phone': '+86 571 87115171'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Provincial Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'China National Biotec Group Company Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}