Safety Clinical Trial
Official title:
A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children
caused by viruses that belong to the enterovirus genus of the picornavirus family. Although
most HFMD cases do not result in serious complications, outbreaks of HFMD caused by
enterovirus 71 (EV71) can present with a high rate of neurological complications, including
meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused
by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic
potential of EV71 clearly requires the attention of world medical community.
The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month
in Jiangsu Province in China. The data from the phase I study suggested that the inactivated
EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese
children and infants. In order to provide more evidence for the immunogenicity of the
vaccine, to further explore the probable immunizing dose and the safety profile of this
vaccine, a phase II clinical trial is planed to conduct.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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