Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-01 @ 11:58 AM
Study NCT ID:
NCT05145166
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2021-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009107', 'term': 'Mumps'}], 'ancestors': [{'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'This study did not involve sample collection.Only adverse reactions/events at 30 minutes, 14 days and 30 days after vaccination of live attenuated mumps vaccine were collected by face-to-face or telephone follow-up.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2021-11-25', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety index-the incidence of local and systemic adverse reactions', 'timeFrame': 'From 0 day to 14 days after vaccination', 'description': 'The incidence of local and systemic adverse reactions from 0 day to 14 days after vaccination.'}, {'measure': 'Safety index-The incidence of local and systemic adverse reactions', 'timeFrame': 'From 0 day to 30 days after vaccination.', 'description': 'The incidence of local and systemic adverse reactions from 0 day to 30 days after vaccination.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mumps']}, 'referencesModule': {'references': [{'pmid': '37733724', 'type': 'DERIVED', 'citation': 'Hu W, Jia N, Meng W, Zhou T, Wang R, Xiong Y, Luan C, Zhang S. Safety analysis of a live attenuated mumps vaccine in healthy adolescents in China: A phase 4, observational, open-label trial. PLoS One. 2023 Sep 21;18(9):e0291730. doi: 10.1371/journal.pone.0291730. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the safety of live attenuated mumps vaccines after large-scale application and accumulate safety data for the application of live attenuated mumps vaccines,and provide scientific basis for the formulation of vaccine immunization prevention strategies.', 'detailedDescription': "This study of live attenuated mumps vaccines is an observational study in which active monitoring and passive monitoring were combined to conduct safety observation.The live attenuated mumps vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.Bao'ji, Xian'yang, Yan 'an and Han'zhong of Shaanxi Province were selected as the research center.A total of 10000 junior high school students under 14 years old who voluntarily received a dose of live attenuated mumps vaccines were be enrolled.Adverse reactions/events at 30 minutes, 14 days and 30 days after vaccination of live attenuated mumps vaccine were were collected by face-to-face or telephone follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study, only junior high school students under 14 years old who were judged by vaccination doctors to be eligible for vaccination and voluntarily received one dose of live attenuated mumps vaccine were enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Junior high school students under 14 years old;\n* The subjects and guardians of the subjects can understand and voluntarily sign the informed consent form ;\n* Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05145166', 'briefTitle': 'Safety Study of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac (Dalian) Vaccine Technology Co., Ltd.'}, 'officialTitle': 'Safety Observation of Live Attenuated Mumps Vaccines in Junior High School Students Under 14 Years Old Vaccinated With Live Attenuated Mumps Vaccines in Shanxi Province', 'orgStudyIdInfo': {'id': 'PRO-MUMPS-4007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Safety group', 'type': 'BIOLOGICAL', 'description': 'All of the participants(N=10000) received one dose of live attenuated mumps vaccine.Vaccine will given by single intramuscular injection(0.5 ml) on day 0.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '721006', 'city': 'Baoji', 'state': 'Shanxi', 'country': 'China', 'facility': 'Baoji Center for Disease Prevention and Control', 'geoPoint': {'lat': 35.90348, 'lon': 111.38866}}, {'zip': '712000', 'city': 'Xianyang', 'state': 'Shanxi', 'country': 'China', 'facility': 'Xianyang Center for Disease Control and Prevention'}, {'zip': '716000', 'city': 'Yan’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Yanan Center for Disease Prevention and Control', 'geoPoint': {'lat': 36.8781, 'lon': 111.80212}}], 'overallOfficials': [{'name': 'Weijun Hu, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaanxi Provincial Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac (Dalian) Vaccine Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}