{"id":"menabcwy","brandName":"MenABCWY","genericName":"menabcwy","companyId":"pfizer","companyName":"Pfizer Inc.","phase":"discontinued","status":"discontinued","modality":"Vaccine","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"MenABCWY is a pentavalent meningococcal conjugate vaccine co-developed by Pfizer and GlaxoSmithKline that protects against invasive meningococcal disease caused by serogroups A, B, C, W, and Y. The vaccine employs conjugate technology linking polysaccharide antigens to carrier proteins to elicit robust T-cell-dependent immune responses across all five serogroups in a single formulation. Although licensed by MHRA in the United Kingdom, the program was discontinued by Pfizer, with development efforts shifting to GSK's continued advancement. Clinical development included 15 trials spanning Phase 2 and Phase 3, demonstrating non-inferiority to sequential meningococcal vaccines and acceptable safety profiles across adolescents and adults. The vaccine addresses a significant unmet need in meningococcal disease prevention by consolidating protection against the most prevalent invasive serogroups globally into one injection, potentially simplifying immunization schedules. Recent publications (2025–2026) document public health impact, cost-effectiveness analyses, and CDC/ACIP recommendations for use in persons aged ≥10 years in the United States.","enrichmentLevel":3,"visitCount":4,"mechanism":{},"administration":{},"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"trials":["NCT02451514","NCT01210885","NCT02212457","NCT03135834","NCT04707391","NCT02946385","NCT03587207","NCT05087056","NCT04502693","NCT04645966","NCT02140762","NCT01992536","NCT04440163","NCT04440176","NCT02285777"],"indications":{"approved":[],"offLabel":[],"pipeline":[]},"commercial":null,"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT02451514","phase":"Phase 2","title":"A Phase 2, Open-label, Controlled, Multi-center Extension Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who ","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":129,"indication":"Meningococcal Disease, Infections, Meningococcal","completionDate":"2015-12-10"},{"nctId":"NCT01210885","phase":"Phase 2","title":"Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB Plus MenACWY Formulations","status":"COMPLETED","sponsor":"Novartis Vaccines","isPivotal":false,"enrollment":495,"indication":"Meningococcal Disease, Meningococcal Meningitis","completionDate":"2011-07"},{"nctId":"NCT02212457","phase":"Phase 2","title":"A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK Me","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":1063,"indication":"Infections, Meningococcal","completionDate":"2016-03-03"},{"nctId":"NCT03135834","phase":"Phase 3","title":"A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN S","status":"COMPLETED","sponsor":"Pfizer","isPivotal":true,"enrollment":1610,"indication":"Meningococcal Vaccine","completionDate":"2022-10-25"},{"nctId":"NCT04707391","phase":"Phase 3","title":"A Phase IIIB, Randomized, Controlled, Observer-blind Study to Evaluate Safety and Immunogenicity of GSK's Meningococcal ABCWY Vaccine When Administered in Healthy Adolescents and Adults, Previously Pr","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":1250,"indication":"Meningitis, Meningococcal","completionDate":"2023-09-29"},{"nctId":"NCT02946385","phase":"Phase 2","title":"A Phase 2b Open-Label Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 Years After the Last Meningococcal Vaccination in Study V102_15 (NCT02212457) and the ","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":604,"indication":"Infections, Meningococcal","completionDate":"2018-02-13"},{"nctId":"NCT03587207","phase":"Phase 2","title":"Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":520,"indication":"Meningitis, Meningococcal","completionDate":"2018-12-19"},{"nctId":"NCT05087056","phase":"Phase 2","title":"A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":302,"indication":"Meningitis, Meningococcal","completionDate":"2027-02-05"},{"nctId":"NCT04502693","phase":"Phase 3","title":"A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Health","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":3657,"indication":"Infections, Meningococcal","completionDate":"2022-09-13"},{"nctId":"NCT04645966","phase":"Phase 2","title":"A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE","status":"TERMINATED","sponsor":"Pfizer","isPivotal":false,"enrollment":326,"indication":"Meningococcal Vaccine","completionDate":"2022-09-15"},{"nctId":"NCT02140762","phase":"Phase 2","title":"A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescent","status":"COMPLETED","sponsor":"Novartis Vaccines","isPivotal":false,"enrollment":305,"indication":"Meningococcal Disease","completionDate":"2015-02"},{"nctId":"NCT01992536","phase":"Phase 2","title":"Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following","status":"COMPLETED","sponsor":"Novartis Vaccines","isPivotal":false,"enrollment":194,"indication":"Meningococcal Disease","completionDate":"2015-04"},{"nctId":"NCT04440163","phase":"Phase 3","title":"A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE","status":"COMPLETED","sponsor":"Pfizer","isPivotal":true,"enrollment":2431,"indication":"Meningococcal Vaccine","completionDate":"2022-07-24"},{"nctId":"NCT04440176","phase":"Phase 2","title":"A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEAR","status":"COMPLETED","sponsor":"Pfizer","isPivotal":false,"enrollment":309,"indication":"Meningococcal Vaccine","completionDate":"2024-01-05"},{"nctId":"NCT02285777","phase":"Phase 2","title":"A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adoles","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":189,"indication":"Meningococcal Disease","completionDate":"2015-06-11"}],"genericFilers":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"labelChanges":[],"nice":null,"revenue":null,"trialStats":{"total":6,"withResults":5},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}