Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT03373656
Status:
UNKNOWN
Last Update Posted:
2022-07-26
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccination for Children of H&O and Their Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014611', 'term': 'Vaccination'}], 'ancestors': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-23', 'studyFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation', 'timeFrame': '2 years'}, {'measure': 'Number of participants with vaccination-related adverse events', 'timeFrame': '2 years'}, {'measure': 'The level of serum antibody increased after vaccination', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccination', 'Childhood', 'Hematologic Malignancy', 'Solid Tumor', 'Immune Deficiency'], 'conditions': ['Vaccination', 'Hematologic Malignancy', 'Solid Tumor, Childhood']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study on compliance, safety and effectivity of vaccination for children with hematologic malignancies or solid tumors and their parents.', 'detailedDescription': 'Children with hematologic malignancies or solid tumors are all facing with immune deficiency due to the disease, the chemotherapy, the hematopoietic stem cell transplantation or the splenectomy, which greatly increases their chance to get infectious diseases. In this study, we will assess the compliance of children with hematologic malignancies or solid tumors and their parents to accept vaccination after finishing treatments, follow up with untoward effect questionnaires to assess the safety, obtain the serum of children patients to test antibody titers and assess the effectivity, provide clues for the study of vaccination in children with hematologic malignancies or solid tumors and provide a scientific basis for the formulation and reunification of vaccination programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children patients(≤18 years) who accepted chemotherapy, hematopoietic stem cell transplantation or splenectomy since our study started.\n2. No history of hepatitis B and measles, do not suffer from other diseases that affect immune function and allergic diseases.\n\nExclusion Criteria:\n\n1. Children patients who did not reach clinical remission after treatment, critically ill or eventually died.\n2. Patients who used monoclonal antibodies, especially anti-tumor necrosis factors.\n3. Intermittent or low-dose chemotherapy or other immunosuppressive drugs users.'}, 'identificationModule': {'nctId': 'NCT03373656', 'briefTitle': 'Vaccination for Children of H&O and Their Parents', 'organization': {'class': 'NETWORK', 'fullName': "Children's Cancer Group, China"}, 'officialTitle': 'Study on Compliance, Safety and Effectivity of Vaccination for Children With Hematologic Malignancies or Solid Tumors and Their Parents', 'orgStudyIdInfo': {'id': 'CCGChina-CCSR-V'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low antibody titers', 'description': 'Antibody titers lower than protection level', 'interventionNames': ['Biological: Vaccination']}, {'type': 'OTHER', 'label': 'high antibody titers', 'description': 'Antibody titers higher than protection level', 'interventionNames': ['Other: No Vaccination']}], 'interventions': [{'name': 'Vaccination', 'type': 'BIOLOGICAL', 'description': 'Patients with higher antibody titers will accept vaccination. There are two vaccines provided in this study:\n\nhepatitis B vaccine measles-rubella combined vaccine', 'armGroupLabels': ['low antibody titers']}, {'name': 'No Vaccination', 'type': 'OTHER', 'description': 'Patients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers.', 'armGroupLabels': ['high antibody titers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi-Jin Gao, MD', 'role': 'CONTACT', 'email': 'gaoyijin@scmc.com.cn', 'phone': '0086-21-38626161'}, {'name': 'Xing-Wei Wang, MD', 'role': 'CONTACT', 'email': 'wangxingwei@scmc.com.cn', 'phone': '0086-21-38626161'}], 'facility': "Shanghai Children's Medical Center", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yi-Jin Gao, MD', 'role': 'CONTACT', 'email': 'gaoyijin@scmc.com.cn', 'phone': '86-21-38626161', 'phoneExt': '82064'}, {'name': 'Xing-Wei Wang, MD', 'role': 'CONTACT', 'email': 'wangxingwei@scmc.com.cn', 'phone': '86-21-38626161', 'phoneExt': '82064'}], 'overallOfficials': [{'name': 'Yi-Jin Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Children's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Cancer Group, China", 'class': 'NETWORK'}, 'collaborators': [{'name': 'Shanghai Pudong District Center for Disease Control and Prevention', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}