智飛生物(300122.SZ):組分百白破-Hib四聯疫苗臨牀試驗申請獲得受理
格隆匯2月21日丨智飛生物(300122.SZ)公佈,由全資子公司北京智飛綠竹生物製藥有限公司研發的吸附無細胞百白破(組分)b型流感嗜血桿菌(結合)聯合疫苗(簡稱“組分百白破-Hib四聯疫苗”)獲得國家藥品監督管理局藥物臨牀試驗申請受理通知書(受理號:CXSL2500171)。自受理之日起60日內,未收到藥審中心否定或質疑意見的,智飛綠竹可以按照提交的方案開展臨牀試驗。
百日咳是由百日咳桿菌引起的一種傳染性極強的急性呼吸系統疾病。百日咳在我國一年四季均可發病,春夏季發病較多,農村發病率高於城市。白喉是由白喉桿菌所引起的一種急性呼吸道傳染病,以發熱,氣憋,聲音嘶啞,咳嗽,咽、扁桃體及其周圍組織出現白色僞膜爲特徵,發病無明顯的季節性。破傷風通常是致死性的感染性疾病,由產毒的破傷風梭狀芽孢桿菌引起,在我國偏遠及醫療衛生條件欠發達地區破傷風的發病及死亡率依然很高。Hib全稱爲b型流感嗜血桿菌,是流感嗜血桿菌的一個亞型,易感人羣主要是5歲以下的兒童,可以引起兒童腦膜炎、肺炎、會厭炎等多種嚴重的感染性疾病,甚至可以導致兒童死亡,是嚴重威脅兒童特別是嬰幼兒健康的一種疾病。組分百白破-Hib四聯疫苗是預防由百日咳、白喉、破傷風以及Hib感染引起疾病的聯合疫苗,可減少接種針次,增強預防接種的依從性。
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