|出版日期||內容資訊||英文 12 Pages
|出版日期: 2019年09月03日||內容資訊: 英文 12 Pages||
GlaxoSmithKline所開發的MenABCW-135Y，是腦膜炎用5價 (A，B，C，W-135，Y) 結合疫苗之一。現在第二階段臨床實驗完成，預計2019年第三階段臨床實驗也將結束，2022年取得美國、歐洲的認證。
GlaxoSmithKline's MenABCW-135Y is a pentavalent meningococcal conjugate vaccine for the A, B, C, W-135, and Y meningococcal strains. With all of the vaccine's announced Phase II trials now complete, Datamonitor Healthcare expects that Phase III trials could start by the end of 2019, and forecasts US and EU approvals in adolescents and adults to occur as early as 2022.
Following its anticipated approvals in the US and EU in 2022, MenABCW-135Y is expected to replace marketed vaccines Bexsero (multicomponent meningococcal serogroup B vaccine; GlaxoSmithKline) and Menveo (quadrivalent oligosaccharide diphtheria CRM-197 conjugate vaccine; GlaxoSmithKline) on the market if it is able to demonstrate non-inferior immunogenicity in persons aged ≥10 years. MenABCW-135Y's broad serotype coverage positions it well to replace Bexsero and Menveo in markets where both of the aforementioned products are reimbursed, as it would be the first meningococcal vaccine on the market to cover all of the major disease-causing serotypes: A, B, C, W, and Y. Thus far, MenABCW-135Y has demonstrated non-inferior immunogenicity to Menveo in Phase II trials, but it will also need to demonstrate non-inferior immunogenicity against serotype B when compared to Bexsero if it hopes to successfully cannibalize Bexsero's and Menveo's market shares.