[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100375298":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":32,"centralContacts":41,"locations":50,"responsibleParty":72,"collaborators":74,"id":88,"slug":27,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":27,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":53,"whyStopped":27,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13,18],{"label":9,"type":6,"description":10,"interventionNames":11},"Arm A : Trumenba®: Standard vaccination","Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose.",[12],"Biological: Trumenba®",{"label":14,"type":6,"description":15,"interventionNames":16},"Arm B:Bexsero®: standard vaccination regimen","Two doses of 0.5 ml each at one month intervals",[17],"Biological: Bexsero®",{"label":19,"type":6,"description":10,"interventionNames":20},"Arm C : Bexsero® Innovative vaccine strategy",[17],[22,28],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Trumenba®","Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Bexsero®","Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe",[14,19],[33,37],{"name":34,"affiliation":35,"role":36},"Odile LAUNAY, MD,PhD","CIC 1417 Clinical Center Investigation","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":40},"MUHAMED-KHEIR TAHA, MD, PHD","Institut Pasteur","STUDY_DIRECTOR",[42,46],{"name":34,"role":43,"phone":44,"phoneExt":27,"email":45},"CONTACT","+33(01)58 41 28 58","odile.launay@aphp.fr",{"name":47,"role":43,"phone":48,"phoneExt":27,"email":49},"Audrey BECLIN-CLABAUX","+33 (0)1 58 41 33 82","audrey.clabaux@aphp.fr",[51],{"facility":52,"status":53,"city":54,"state":27,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"I-REIVAC\u002FCIC1417 Cochin Hospital, AP-HP","RECRUITING","Paris","75014","France","FR",{"type":59,"coordinates":60},"Point",[61,62],2.3488,48.85341,{"lat":62,"lon":61},[65,66,70],{"name":34,"role":43,"phone":44,"phoneExt":27,"email":45},{"name":67,"role":43,"phone":68,"phoneExt":27,"email":69},"Mouna Fellague Chebra, project manager","+33 (0)1 58 41 33 54","mouna.fellaguechebra@aphp.fr",{"name":71,"role":36,"phone":27,"phoneExt":27,"email":27},"Odile LAUNAY, MD, PhD",{"type":73,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[75,77,79,81,84,86],{"name":76,"class":6},"EUCLID Clinical Trial Platform",{"name":78,"class":6},"Recherche Clinique Paris Descartes Necker Cochin Sainte Anne",{"name":80,"class":6},"CIC 1417 Cochin-Pasteur",{"name":82,"class":83},"Innovative clinical research in vaccinologie (I-REIVAC)","UNKNOWN",{"name":39,"class":85},"INDUSTRY",{"name":87,"class":6},"URC-CIC Paris Descartes Necker Cochin","100375298",false,"NCT04166656","Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.","Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia","SPLEMENGO","Inclusion Criteria:\n\n1. Male or female, \\>=18 to \\\u003C=75 years old.\n2. Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film\n3. Splenectomy confirmed by consultation and\u002For hospitalization report or the ultrasound if it has been performed during the routine follow-up\n4. Women of childbearing age must have an effective contraception during the first 9 months of the study.\n5. Participants must give written consent prior to any trial procedure\n6. Participants must be covered by social security regimen or equivalent.\n7. Participants will be followed during the 4 years from the inclusion visit.\n\nExclusion Criteria:\n\n1. History of meningococcal vaccination B.\n2. History of anaphylaxis post vaccination.\n3. Known allergy to any components (active substances or excipients) of both vaccines.\n4. Patients who cannot stop antibiotics 3 days before blood collection.\n5. Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 7 months of the study (except the meningococcal ACWY vaccine, the anti-pneumococcal vaccine, the Haemophilus influenzae type B vaccine, the anti-Covid-19 vaccine), annual influenza vaccination which is permitted 2 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).\n6. Parenteral Ig within the 3 months prior to VS or planned during the study.\n7. Chemotherapy agents within 6 months prior M0 or planning to take any during the study.\n8. Steroids (\\> 10mg\u002Fday; \\> 14 days) within the month preceding M0 or planning to take any during the study.\n9. Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo \u002F autograft, primary immunodeficiency, nephrotic syndrome, evolutive cancer, cirrhosis, known infection to HIV;\n10. Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.\n11. Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.\n12. Severe acute febrile illness within the week before inclusion.\n13. Registration for any other clinical trial throughout the trial period except observational study.","ALL","18 Years","75 Years",{"count":99,"type":100},84,"ESTIMATED","INTERVENTIONAL",[103],"PHASE3","The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.",[106],"Splenectomy",[108,109,110],"Meningococcal B vaccine","vaccine strategies","splenectomized individuals","2025-11-17",{"date":113,"type":114},"2025-11-20","ACTUAL",{"date":116,"type":114},"2022-09-15",{"date":118,"type":100},"2028-10",{"name":5,"class":6},1]