[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100135036":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":41,"locations":46,"responsibleParty":59,"collaborators":41,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":41,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":41,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":86,"whyStopped":41,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"5rMenB","EXPERIMENTAL","Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV) (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.",[13],"Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)",{"label":15,"type":10,"description":16,"interventionNames":17},"5rMenB+OMV NZ","Subjects who had received four doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of the same vaccine, at 40 months of age in the present study.",[18],"Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine.",{"label":20,"type":10,"description":21,"interventionNames":22},"3rMenB","Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine without OMV (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"3rMenB+OMV NZ","Subjects who had previously received one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine (at 12 months of age) were administered two doses of the same vaccine, at 40 and 42 months of age in the present study.",[18],{"label":28,"type":10,"description":29,"interventionNames":30},"Naive_4042","Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 40 and 42 months of age in the present study.",[18],{"label":32,"type":10,"description":33,"interventionNames":34},"Naive_6062","Vaccine-naive subjects who received two catch-up doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 60 and 62 months of age in the present study.",[18],[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BIOLOGICAL","Meningococcal (group B) multicomponent recombinant adsorbed vaccine.","Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.",[24,15,28,32],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)","Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).",[20,9],[47],{"facility":48,"status":41,"city":49,"state":41,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":41},"Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital","Oxford","OX3 7LJ","United Kingdom","UK",{"type":54,"coordinates":55},"Point",[56,57],-1.25596,51.75222,{"lat":57,"lon":56},{"type":60,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100135036","phase-2-extension-study-evaluating-antibody-persistence-and-safety-tolerability-and-immunogenicity-of-booster-doses-of-novartis-rmenbomv-nz-vaccine-in-healthy-uk-children-who-previously-received-one-or-four-doses-of-the-same-vaccine-100135036",true,"NCT01027351","Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine","A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naïve Children and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Novartis Vaccine as Infants in Study V72P6","Inclusion Criteria:\n\n* Healthy 40 to 44-months-old children, who participated and completed the study V72P6 (NCT00381615; follow-on subjects)\n* Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)\n\nExclusion Criteria:\n\n* Previous ascertained or suspected disease caused by N. meningitidis\n* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component\n* Any serious chronic or progressive disease\n* Known or suspected impairment\u002Falteration of the immune system\n* Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)","ALL","40 Months","62 Months",{"count":72,"type":73},163,"ACTUAL","INTERVENTIONAL",[76],"PHASE2","The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP\u002FIPV and MMR vaccinations, if they have not already received these vaccines prior to enrollment.",[79],"Meningococcal Disease",[81,82,83,84,85],"Children","Pre-school","Meningococcal disease","Prevention","Vaccination","COMPLETED","2018-09-10",{"date":89,"type":73},"2018-10-09",{"date":91,"type":41},"2010-01",{"date":93,"type":73},"2012-05",{"name":95,"class":6},"Novartis Vaccines",1]