Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT03160820
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}], 'ancestors': [{'id': 'D018185', 'term': 'Morbillivirus 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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}], 'ancestors': [{'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 873}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2017-05-10', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity of the MMR vaccines in terms of antibody concentration', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'For measles virus, seroresponse is defined as post-vaccination anti-measles virus antibody concentration (Ab conc) \\>200 mIU/mL.\n\nFor mumps virus, seroresponse is defined as post-vaccination anti-mumps virus Ab conc \\>100 IU/mL.\n\nFor rubella virus, seroresponse is defined as post-vaccination anti-rubella virus Ab conc \\>20 IU/mL.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Measles', 'Mumps', 'Rubella', 'Adverse Event Following Immunisation']}, 'descriptionModule': {'briefSummary': "This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with measles-rubella(MR).", 'detailedDescription': "This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older.\n\nThe MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with MR.\n\nImmune efficacy and safety will be compared among different immunization schedules,including inoculation doses,enhanced immunity age,vaccination interval time.\n\nAntibody persistence of 1 dose of MMR vaccine will be evaluated in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy children; 150 subjects 18 months old; 150 subjects 4 years old;300 subjects 5 years old; 150 subjects 6 years old; their guardians signed informed consent;\n* undiagnosed as measles, mumps and rubella;\n* in good health as determined by the outcome of medical history, physical examination and clinical judgment; suitable to MMR immunization;\n* guardians would comply with the requirements of the protocol;\n* immunized with MR or measles vaccine(MV) at 8 months old;immunized with MMR at 18 months old(not applicable to subjects 18 months old); unvaccinated by biological products within one month;\n* Axillary temperature ≤37℃;\n* the local household population or permanent population;\n\nExclusion Criteria:\n\n* history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(any previous vaccination history of allergies and egg allergy history);\n* Current confirmed as acute disease, severe chronic diseases or acute development of chronic diseases;\n* Participating in another clinical trial at the same time;'}, 'identificationModule': {'nctId': 'NCT03160820', 'briefTitle': "Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centers for Disease Control and Prevention, China'}, 'officialTitle': "Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children", 'orgStudyIdInfo': {'id': 'BJCDCWJ201601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'one dose of MMR', 'description': 'Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old.', 'interventionNames': ['Biological: Measles, mumps and rubella Combined Vaccine, Live']}, {'type': 'OTHER', 'label': '30 months after two doses of MMR', 'description': 'Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially.', 'interventionNames': ['Biological: Measles, mumps and rubella Combined Vaccine, Live']}, {'type': 'OTHER', 'label': '42 months after two doses of MMR', 'description': 'Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially.', 'interventionNames': ['Biological: Measles, mumps and rubella Combined Vaccine, Live']}, {'type': 'OTHER', 'label': '54 months after two doses of MMR', 'description': 'Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially.', 'interventionNames': ['Biological: Measles, mumps and rubella Combined Vaccine, Live']}], 'interventions': [{'name': 'Measles, mumps and rubella Combined Vaccine, Live', 'type': 'BIOLOGICAL', 'otherNames': ['Beijing Tiantan Biological Products Co., Ltd'], 'description': 'Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.', 'armGroupLabels': ['30 months after two doses of MMR', '42 months after two doses of MMR', '54 months after two doses of MMR', 'one dose of MMR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050021', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '010031', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Inner Mongolia Center for Disease Control and Prevention', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'zip': '030012', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '300011', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Center for Disease Control and Prevention', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Jiang Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Center for Diseases Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Beijing Tiantan Biological Products Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Immunization and Prevention,Beijing Center for Disease Control and Prevention. Principal Investigator, Public Health Chief Physician', 'investigatorFullName': 'Wu Jiang', 'investigatorAffiliation': 'Centers for Disease Control and Prevention, China'}}}}