Clinical evaluation of the lot-to-lot consistency of an enterovirus 71 vaccine in a commercial-scale phase IV clinical trial.
Jinhua ChenPengfei JinXiaoqi ChenQunying MaoFanyue MengXinguo LiWei ChenMeizhi DuFan GaoPei LiuXiujuan LiChangfu GuoTingbo XieWeiwei LuQingliang LiLi LiXing YanXiang GuoHongqiao DuXiuling LiKai DuanFeng-Cai ZhuPublished in: Human vaccines & immunotherapeutics (2022)
The EV71 vaccine was highly immunogenic and safe in children aged 6-35 months, and 6 consecutive batches produced by the two bioreactors with different specifications were consistent.