Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT02712203
Status:
UNKNOWN
Last Update Posted:
2016-03-18
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MMR and MMRV Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-08-26', 'releaseDate': '2021-08-02'}], 'estimatedResultsFirstSubmitDate': '2021-08-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022542', 'term': 'Measles-Mumps-Rubella Vaccine'}, {'id': 'C050102', 'term': 'measles, mumps, rubella, varicella vaccine'}, {'id': 'C577557', 'term': 'Priorix-Tetra 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5808}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV', 'timeFrame': 'At day 42 after administration of a dose of MMR or MMRV vaccine', 'description': 'Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL. The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL (performed on seronegative subjects prior to vaccination).'}], 'secondaryOutcomes': [{'measure': 'Injection site reaction', 'timeFrame': 'Days 0-3 after vaccination', 'description': 'Injection site reaction is defined by the presence of pain, redness and swelling'}, {'measure': 'Systemic symptoms', 'timeFrame': 'Days 0 - 42 after administration of a dose of MMR or MMRV vaccine', 'description': 'Will include fever (defined as rectal temperature ≥38°C), general malaise and measles-like rash'}, {'measure': 'Long term seropositivity rates and anti-measles antibody titers after vaccination with MMR or MMRV', 'timeFrame': '2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines', 'description': 'Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Measles vaccine', 'Priorix', 'Priorix-Tetra', 'Age at vaccination'], 'conditions': ['Measles']}, 'referencesModule': {'references': [{'pmid': '19665608', 'type': 'BACKGROUND', 'citation': 'Czajka H, Schuster V, Zepp F, Esposito S, Douha M, Willems P. A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra): immunogenicity and safety profile. Vaccine. 2009 Nov 5;27(47):6504-11. doi: 10.1016/j.vaccine.2009.07.076. Epub 2009 Aug 7.'}, {'pmid': '18600190', 'type': 'BACKGROUND', 'citation': 'Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22.'}, {'pmid': '16395096', 'type': 'BACKGROUND', 'citation': 'Knuf M, Habermehl P, Zepp F, Mannhardt W, Kuttnig M, Muttonen P, Prieler A, Maurer H, Bisanz H, Tornieporth N, Descamps D, Willems P. Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Pediatr Infect Dis J. 2006 Jan;25(1):12-8. doi: 10.1097/01.inf.0000195626.35239.58.'}]}, 'descriptionModule': {'briefSummary': "Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in their second year of life.The purpose of this study is to assess the effect of the age at administration of the first dose on the reactogenicity and immunogenicity of the measles component of these vaccines.\n\nIn addition, this study will evaluate if the effect of the age at first dose is modified by the type of vaccine administered."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '22 Months', 'minimumAge': '11 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged 11 to 22 months selected to participate in clinical trials to assess the safety and immunogenicity of the GSK biological Priorix-Tetra™ in Germany, Austria, Finland, Greece, Poland, Czech Republic, Italy, Lithuania, Norway, Romania, Russian Federation, Slovakia, Sweden, United States and Puerto Rico.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female subject between 11 to 22 months at the time of first vaccination.\n* Written informed consent obtained from the parent/guardian of the subject.\n\nExclusion Criteria:\n\n* History of previous measles, mumps, rubella and/or varicella vaccination or disease or known exposure to any of these diseases within 30 days prior to the inclusion in the study.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, included the chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying drugs within six months prior to the firs vaccine dose.\n* History of any neurologic disorders or seizures.\n* History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines.\n* Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination'}, 'identificationModule': {'nctId': 'NCT02712203', 'briefTitle': 'MMR and MMRV Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Measles-mumps-rubella and Measles-mumps-rubella-varicella Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.', 'orgStudyIdInfo': {'id': '200783'}}, 'armsInterventionsModule': {'armGroups': [{'label': '12 months', 'description': 'MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age', 'interventionNames': ['Biological: MMR vaccine / MMRV vaccine']}, {'label': '13 months', 'description': 'MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age', 'interventionNames': ['Biological: MMR vaccine / MMRV vaccine']}, {'label': '14 months', 'description': 'MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age', 'interventionNames': ['Biological: MMR vaccine / MMRV vaccine']}, {'label': '15 months or more', 'description': 'MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older', 'interventionNames': ['Biological: MMR vaccine / MMRV vaccine']}], 'interventions': [{'name': 'MMR vaccine / MMRV vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Priorix®', 'Priorix-Tetra®'], 'description': 'Subcutaneous injection, two doses', 'armGroupLabels': ['12 months', '13 months', '14 months', '15 months or more']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gaston De Serres, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Quebec-Universite Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Gaston De Serres', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-08-02', 'type': 'RELEASE'}, {'date': '2021-08-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gaston De Serres, MD, PhD, CHU de Quebec-Universite Laval'}}}}