艾美疫苗(06660.HK):13價結合肺炎疫苗III期臨牀試驗已入尾聲及即將開始統計揭盲
格隆匯10月17日丨艾美疫苗(06660.HK)發佈公吿,集團13價肺炎球菌多糖結合在研疫苗的III 期臨牀試驗已於2022年2月在雲南臨滄、大理等5個現場啟動受試者入組工作,共計入組受試者3,780例。目前處於全程疫苗接種後6個月血樣採集階段,截至目前已完成基礎免疫MOPA血清檢測,即將進入統計揭盲工作。
此前,該款疫苗的I期臨牀試驗已於2021年2月在廣西柳城疾病預防控制中心啟動受試者入組工作,於2021年6月完成全部200例2月齡至59週歲受試者入組工作,截至目前已獲得的試驗結果,顯示了該款疫苗具有良好的安全性和免疫原性。
該款疫苗用於預防由該款疫苗包含的13種肺炎球菌血清型(1型、3型、4型、5 型、6A型、6B型、7F型、9V型、14型、18C型、19A型、19F型和23F型)感染引起的相關疾病。集團已完成建設該款疫苗的生產車間,設計產能3,000萬劑。13價肺炎球菌結合疫苗是世界上最暢銷的疫苗品種之一。根據輝瑞公司2022年年報,輝瑞公司的肺炎球菌結合疫苗在2022年度的全球銷售額約為63.37億美元。
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