[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100208568":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":35,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":34,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":34,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":82,"whyStopped":34,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"The Immunobiological Technology Institute (Bio-Manguinhos) \u002F Oswaldo Cruz Foundation (Fiocruz)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MMR Bio-Manguinhos","EXPERIMENTAL","Arm 1:1170 children will receive MMR Bio-Manguinhos, 3 diferents lots",[13],"Biological: MMR Bio-Manguinhos",{"label":15,"type":16,"description":17,"interventionNames":18},"MMR GlaxoSmithKline","ACTIVE_COMPARATOR","Arm 2:390 children will receive MMR GlaxoSmithKline",[19],"Biological: MMR GlaxoSmithKline",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","1170 children will receive 100% produced by Bio-Manguinhos, 3 diferents lots. Application of a 0.5 ml dose, subcutaneous 390 children will receive 0,5 ml, subcutaneous, MMR GlaxoSmithKline",[9],[15],{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"390 children will receive 0,5 ml MMR GlaxoSmithKline",[15],[9],[31],{"name":32,"affiliation":5,"role":33},"Eliane Matos Santos","PRINCIPAL_INVESTIGATOR",null,[36],{"facility":37,"status":34,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":34},"Instituto Evandro Chagas","Belém","Pará","67030-000","Brazil","BR",{"type":44,"coordinates":45},"Point",[46,47],-48.50444,-1.45583,{"lat":47,"lon":46},{"type":50,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[52],{"name":53,"class":54},"GlaxoSmithKline","INDUSTRY","100208568","phase-3-study-of-immunogenicity-reactogenicity-and-safety-of-the-combined-measles-mumps-and-rubella-vaccine-produced-by-bio-manguinhosfiocruz-in-children-12-15-months-of-age-followed-by-tetraviral-vaccine-in-children-15-18-months-100208568",false,"NCT01991899","Study of Immunogenicity, Reactogenicity and Safety of the Combined Measles, Mumps and Rubella Vaccine Produced by Bio-Manguinhos\u002FFiocruz in Children 12-15 Months of Age, Followed by Tetraviral Vaccine in Children 15-18 Months.","Inclusion Criteria:\n\n* Children of both sexes\n* Age between 12 to 15 months .\n* Child in good health , without significant past medical history personal , such as genetic syndromes , epilepsy , diabetes , severe infections and immune dysfunctions .\n* Consent of father or mother , or legal guardian of the child to participate in the study and signing the Informed Consent Form.\n* Disposition of the father or mother, or legal guardian to provide name, address, phone and other information so you can get in touch with this, if necessary .\n* The responsible person be able to understand the risks of the experimente\n* The responsible person be able to understand and sign the informed consent form . If the charge is not able to sign ( illiterate ) the IC may be signed by an impartial witness who has followed the entire procedure .\n* Availability return to collect post-vaccination - The research subjects may not be participating in another clinical study during this study.\n* Not having received injectable live virus vaccine in the last 30 days.\n\nExclusion Criteria:\n\n* \\- Children with a history of measles, rubella and \u002F or mumps .\n* Have received MMR or tetraviral previously documented in book vaccination ( eg . : In situations of conducting national campaign or blocking vaccination before suspected cases ).\n* Have received a blood transfusion , including immunoglobulins , less than 1year .\n* Skin lesions at sites of venipuncture .\n* Child subject to abnormal bleeding after injections .\n* Using the last 6 months at doses of corticosteroids and other immunosuppressive immunosuppressants.\n* Fever on the day of inclusion or in the 3 days prior to the inclusion in this case may be rescheduled for inclusion 14 days after fever subsides .\n* Antibiotic use on the day of inclusion or in the last 7 days prior to inclusion - in this case , may be rescheduled for inclusion after 14 days from the last day of antibiotic use .\n* Significant abnormality on physical examination the day of enrollment . Known systemic hypersensitivity to neomycin or any other component of the vaccine .\n* Individuals with a history of severe allergy , anaphylaxis to egg proteins .\n* Have received live attenuated vaccine , as the vaccine for yellow fever in the 30 days prior to vaccination with MMR and the 2nd and 3rd collections .",true,"ALL","12 Months","18 Months",{"count":66,"type":67},1560,"ACTUAL","INTERVENTIONAL",[70],"PHASE3","It is a clinicaltrial Phase III , randomized, double -blind , 4-arm (390 each one):\n\nThis study will include 1560 children and will use 3 batches of vaccine produced by Bio - Manguinhos with viral bulk of GSK combined measles , mumps and rubella applied in healthy children 12-15 months of age, and 01 batch of MMR to reference( GSK ), applied in healthy children aged 12-15 months old . The vaccine is administered as MMR 1st dose.\n\nTwo hypotheses are tested :\n\n1. Consistency of production ( equivalence between batches )of 3 batches of vacines(TV1, TV2 , TV3 Bio- Manguinhos). Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro), ie, the measles, mumps and rubella in Brazil is as immunogenic and safe as the measles, mumps and rubella reference, already used in routine NIP (production Bio-Manguinhos\u002FFIOCRUZ with viral concentrate, bulk, GSK).\n\n   The MMR vaccine (Bio-TV) will have the same composition (vaccine strains) and the same method of production of MMR (TV-GSK): Wistar RA27 \u002F 3 rubella, Schwarz strain of measles vaccine, and strain RIT 4385 - derived from the Jeryl Lynn strain of mumps vaccine.\n\n   As 2nd dose, children receive the vaccine tetraviral measles-mumps-rubella-varicella, aged 15-18 months, according to the guidance of the National Immunization Program.\n2. Noninferiority vaccine Bio TV (Fiocruz, Rio de Janeiro):the measles, mumps and rubella vaccine in Brazil is as immunogenic and safe as the measles, mumps and rubella reference, already used in routine NIP (production Bio-Manguinhos\u002FFIOCRUZ with viral concentrate, bulk, GSK).\n\nReturns for blood sampling will be scheduled for 51 days, ranging from 42 to 60 days after dose of MMR vaccine dose and after tetraviral. We will colect the firt blood sample before the first vaccination too.\n\nIt will describe the major adverse events observed after vaccination , comparing their frequency in groups of MMR vaccine with the Brazilian reference vaccine .",[73,74,75,76],"Measles","Mumps","Rubella","Varicella",[78,79,80,81],"Measles, mumps and rubella vaccine","Tetraviral vaccine","Immunogenicity, Reactogenicity and Safety","Consistency of production","COMPLETED","2016-07-07",{"date":85,"type":86},"2016-07-11","ESTIMATED",{"date":88,"type":34},"2015-02",{"date":90,"type":67},"2016-07",{"name":5,"class":6},1]