原始来源记录
决策级临床试验登记变更
Vaxcyte推进VAX-31成人3期项目；OPUS-1顶线数据预计2026年Q4
Vaxcyte已与FDA达成一致，确定了全面的VAX-31成人3期项目，并启动了三项3期试验（OPUS-1、OPUS-2、OPUS-3），以支持计划中的BLA提交。关键性OPUS-1非劣效性试验的安全性、耐受性和免疫原性顶线数据预计于2026年Q4公布，OPUS-2和OPUS-3数据预计于2027年上半年公布。VAX-31婴儿2期剂量探索研究的入组也已完成，顶线数据预计于2027年上半年末公布。
关键事实
来源摘录
EX-99.1 2 pcvx-20260224xexx991.htm EX-99.1 Document Exhibit 99.1 Vaxcyte Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Comprehensive VAX-31 Adult Phase 3 Clinical Program, Finalized in Consultation and Alignment with FDA, Advances with Three Phase 3 Studies Underway to Support Planned BLA Submission Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027 Enrollment Completed in VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose Expected Either Sequentially or Together by End of First Half of 2027 Company Advancing Early-Stage Pipeline, Expects to I