{"id":"trumenba","rwe":[{"pmid":"39983538","year":"2025","title":"Nanoparticles displaying fHbp elicit an enhanced antibody response against meningococcal B isolates compared to low valency fHbp antigens.","journal":"Vaccine"},{"pmid":"38521080","year":"2024","title":"Use of a meningococcal group B vaccine (4CMenB) in populations at high risk of gonorrhoea in the UK.","journal":"The Lancet. Infectious diseases"},{"pmid":"38072758","year":"2024","title":"Co-administration with Men-B vaccine increases Rotavirus vaccination coverage: A 5-year regionwide retrospective cohort study (STORM study).","journal":"Vaccine"},{"pmid":"37257838","year":"2023","title":"Serum bactericidal activity against circulating and reference strains of meningococcal serogroup B in the United States: A review of the strain coverage of meningococcal serogroup B (MenB) vaccines in adolescents and young adults.","journal":"Human vaccines & immunotherapeutics"},{"pmid":"36863060","year":"2023","title":"Healthy Vaccinee Bias and MenB-FHbp Vaccine Effectiveness Against Gonorrhea.","journal":"Sexually transmitted diseases"}],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT04440163","NCT04645966","NCT00808028","NCT05873751","NCT00780806","NCT04893811","NCT00879814","NCT07197762","NCT02534935","NCT03135834","NCT00798304","NCT00297687"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2009","type":"negative","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infa) — Meningitis, Meningococcal. Trial terminated early."},{"date":"2012","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults) — Meningitis, Meningococcal"},{"date":"2022","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age) — Meningococcal Vaccine"},{"date":"2023","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immu) — Meningococcal Vaccine"}],"aiSummary":"Trumenba is a vaccine antigen used to prevent infection by Neisseria meningitidis, specifically targeting serogroup B. It works by inducing an immune response against the factor H binding protein of Neisseria meningitidis.","brandName":"Trumenba","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Vaccine","drugClass":"Trumenba is a sterile, recombinant vaccine targeting Neisseria meningitidis serogroup B. It contains","explanation":"","oneSentence":"Trumenba is a sterile, recombinant vaccine targeting Neisseria meningitidis serogroup B. It contains","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"trumenba","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Neisseria Meningitidis","phase":"preclinical","trialId":"","patients":null,"diseaseId":"vaccines","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04440163","phase":"Phase 3","title":"MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age","status":"Completed","sponsor":"Pfizer","isPivotal":true,"enrollment":2431,"indication":"Meningococcal Vaccine","completionDate":"2022-07","primaryEndpoint":"The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the c"},{"nctId":"NCT04645966","phase":"Phase 2","title":"A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infant","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":326,"indication":"Meningococcal Vaccine","completionDate":"2022-09","primaryEndpoint":"The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age."},{"nctId":"NCT00808028","phase":"Phase 2","title":"A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":538,"indication":"Meningitis, Meningococcal","completionDate":"2014-03","primaryEndpoint":"The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old."},{"nctId":"NCT05873751","phase":"N/A","title":"A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1307378,"indication":"Gonorrhea","completionDate":"2024-03","primaryEndpoint":"Brief Summary: The main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection."},{"nctId":"NCT00780806","phase":"Phase 1/2","title":"Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":60,"indication":"Meningitis, Meningococcal","completionDate":"2010-05","primaryEndpoint":"The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development."},{"nctId":"NCT04893811","phase":"Phase 4","title":"Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immu","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":53,"indication":"Meningococcal Vaccine","completionDate":"2023-09","primaryEndpoint":"The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing ant"},{"nctId":"NCT00879814","phase":"Phase 1","title":"Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":48,"indication":"Meningitis, Meningococcal","completionDate":"2012-07","primaryEndpoint":"The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults."},{"nctId":"NCT07197762","phase":"Phase 4","title":"MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults","status":"Recruiting","sponsor":"Emory University","isPivotal":false,"enrollment":125,"indication":"Neisseria Meningitidis","completionDate":"2026-12","primaryEndpoint":"The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine."},{"nctId":"NCT02534935","phase":"Phase 2","title":"Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":396,"indication":"Meningococcal B Disease","completionDate":"2017-08","primaryEndpoint":"The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease."},{"nctId":"NCT03135834","phase":"Phase 3","title":"A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pe","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1610,"indication":"Meningococcal Vaccine","completionDate":"2022-10","primaryEndpoint":"This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule."},{"nctId":"NCT00798304","phase":"Phase 2","title":"Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infa","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":46,"indication":"Meningitis, Meningococcal","completionDate":"2009-06","primaryEndpoint":"The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants."},{"nctId":"NCT00297687","phase":"Phase 1","title":"Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Hea","status":"Completed","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":108,"indication":"Meningitis, Meningococcal","completionDate":"","primaryEndpoint":"To determine the safety \\& immunogenicity of a potential vaccine against meningococcal B disease"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"rxcui":"1593136","chemblId":"CHEMBL6068499","pubchemSID":"381129604"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Vaccine","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":2,"withResults":2},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}