drugset / Trial / NCT02367664

A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants

NCT02367664 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.

Timeline

Start
2014-10
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Vero cell-derived inactivated Japanese Encephalitis vaccine Vaccine 0.5 ml —
Comparator inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) Vaccine 0.5 ml —

Indications