Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-01-03 @ 5:29 AM
Study NCT ID:
NCT01874457
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2013-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}, {'id': 'D008457', 'term': 'Measles'}], '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'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D018185', 'term': 'Morbillivirus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022542', 'term': 'Measles-Mumps-Rubella Vaccine'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D008458', 'term': 'Measles Vaccine'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D009108', 'term': 'Mumps Vaccine'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-13', 'studyFirstSubmitDate': '2013-06-07', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunoresponse after first dose', 'timeFrame': '42 days', 'description': 'Assess the immunoresponse for measles, mumps and rubella after vaccination with MMR in children 12-23 months and 29 days old, in the routine of National Immunization Program (NIP) in health units in the city of Rio de Janeiro.'}], 'secondaryOutcomes': [{'measure': 'Immunoresponse after revaccination', 'timeFrame': '42 days', 'description': 'To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mumps', 'Rubella', 'Measles']}, 'descriptionModule': {'briefSummary': 'On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose.', 'detailedDescription': 'Given the above and considering: (1) future clinical study with the MMR vaccine produced entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2) the importance to the National Immunization Program (NIP) to provide the population a MMR vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the MMR vaccine produced by BioManguinhos.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '12 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children 12-23 months and 29 days old, in the routine of PNI in health units in the city of Rio de Janeiro.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children of both sexes;\n* Age between 12 months to 23 months and 29 days;\n* Child in good health, with no significant past medical history;\n* Have completed blood sampling before vaccination;\n* Have not been vaccinated with MMR.\n* Agreement by parents/tutors with the child's participation in the study and signing of the Informed Consent Form (ICF);\n* Parents/Tutors provide name, address, telephone number and other information for the contact if necessary;\n* Parents/Tutors able to understand the risks of the experiment, although minimal;\n* Parents/Tutors able to understand and sign the informed consent form.\n* Availability of return for collecting post-vaccination samples.\n\nExclusion criteria:\n\n* Children with a history of measles, rubella and / or mumps.\n* Having received MMR vaccine previously, as documented in vaccination card.\n* Having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months.\n* Skin lesions at sites of venipuncture.\n* Child subject to abnormal bleeding after injections.\n* Use within 6 months of corticosteroids (excluding topical or aerosol) and immunosuppressants."}, 'identificationModule': {'nctId': 'NCT01874457', 'briefTitle': 'Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)', 'organization': {'class': 'OTHER', 'fullName': 'The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)'}, 'officialTitle': 'A Serological Study of Measles, Mumps and Rubella in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella) in Health Centers Where a Phase III Study Should be Conducted', 'orgStudyIdInfo': {'id': 'ASCLIN/002/2008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MMR (Mumps, Measles and Rubella)', 'type': 'BIOLOGICAL', 'description': 'MMR (Mumps, Measles and Rubella)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21040-360', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Bio-Manguinhos/Fiocruz', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Glória Regina da Silva e Sá, Doctorate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Immunobiological Technology Institute (Bio-Manguinhos)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}