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智飛生物(300122.SZ):組份百白破疫苗進入Ⅰ期臨牀試驗
格隆匯 03-09 18:31

格隆匯 3 月 9日丨智飛生物(300122.SZ)公佈,公司近日獲悉由全資子公北京智飛綠竹生物製藥有限公司(智飛綠竹)研發的吸附無細胞百白破(組份)聯合疫苗(“組份百白破疫苗”)於近日在湖南省常德市石門縣疾病預防控制中心開始I期臨牀試驗

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偽膜為特徵,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,在我國偏遠及醫療衞生條件欠發達地區破傷風的發病及死亡率依然很高。百白破疫苗是針對百日咳、白喉、破傷風三種疾病的聯合疫苗。

截至目前,國產無細胞百白破疫苗為採用共純化技術製備。智飛綠竹研制的組份百白破疫苗是新一代的無細胞百白破疫苗,採用單獨純化的百日咳有效組份配製出的質量均一疫苗產品,可替代目前免疫規劃疫苗中的百白破疫苗,市場前景廣闊。該產品於201991公吿獲得國家藥品監督管理局的《臨牀試驗通知書》

組份百白破疫苗I期臨牀試驗在湖南省常德市石門縣疾病預防控制中心評價疫苗接種於兒童和嬰幼兒的安全性

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