Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-29 @ 11:40 PM
Study NCT ID:
NCT01830257
Status:
UNKNOWN
Last Update Posted:
2013-04-12
First Post:
2013-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-11', 'studyFirstSubmitDate': '2013-03-31', 'studyFirstSubmitQcDate': '2013-04-11', 'lastUpdatePostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence about AEFI', 'timeFrame': '1.5years', 'description': 'Incidence about AEFI comes from the rate between number of adverse event and the all quantity for immunization about MR and APDT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adverse Reaction to Drug']}, 'descriptionModule': {'briefSummary': 'The investigators would remind the guardians of observation after immunization via sending short message and collect the information of AEFI by two ways, short message/telephone and website questionnaire.', 'detailedDescription': 'The investigators will compare the rate between active and inactive surveillance of AEFI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* According with the regular vaccination\n* Immunization the acellular pertussis diphtheria tetanus vaccine and Measles and rubella combined vaccine\n\nExclusion Criteria:\n\n* Disapproval the AEFI information'}, 'identificationModule': {'nctId': 'NCT01830257', 'acronym': 'AEFI', 'briefTitle': "Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Beijing Center for Disease Control and Prevention'}, 'officialTitle': 'Phase 4 Study of MR and APDT Vaccine', 'orgStudyIdInfo': {'id': 'BJCDPC-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sending message', 'description': "The investigators would send the tip to the children's guardian", 'interventionNames': ['Other: sending message']}], 'interventions': [{'name': 'sending message', 'type': 'OTHER', 'description': 'Sending the suggestive short message', 'armGroupLabels': ['sending message']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhaoyun Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chaoyang District Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}