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Clinical evaluation for batch consistency of an inactivated enterovirus 71 vaccine in a large-scale phase 3 clinical trial

The demonstration of batch-to-batch consistency to confirm the reliability of the manufacturing process has become a mandatory step in vaccine development. This is a post-hoc analysis aimed to provide more solid evidence on the immunogenicity and consistency of 3 consecutive batches of a novel inact...

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Bibliografske podrobnosti
izdano v:Hum Vaccin Immunother
Main Authors: Chen, Yi-Juan, Meng, Fan-Yue, Mao, Qunying, Li, Jing-Xin, Wang, Hua, Liang, Zheng-Lun, Zhang, Yun-Tao, Gao, Fan, Chen, Qing-Hua, Hu, Yuemei, Ge, Zi-Jun, Yao, Xin, Guo, Hui-Jie, Zhu, Feng-Cai, Li, Xiu-Ling
Format: Artigo
Jezik:Inglês
Izdano: Taylor & Francis 2014
Teme:
Online dostop:https://ncbi.nlm.nih.gov/pmc/articles/PMC4896521/
https://ncbi.nlm.nih.gov/pubmed/24633366
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4161/hv.28397
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