对6-11月龄健康婴幼儿进行的纯化乙型脑炎灭活疫苗(Vero细胞)单中心、随机、盲态、阳性对照Ⅲ期临床试验
[Translation] A single-center, randomized, blinded, positive-controlled phase III clinical trial of purified inactivated Japanese encephalitis vaccine (Vero cells) in healthy infants aged 6-11 months
评价山东恒业生物技术有限公司生产的纯化乙型脑炎灭活疫苗(Vero细胞)在6-11月龄常住健康婴幼儿中基础免疫的免疫原性和安全性。
[Translation] To evaluate the immunogenicity and safety of purified inactivated Japanese encephalitis vaccine (Vero cells) produced by Shandong Hengye Biotechnology Co., Ltd. for basic immunization in healthy infants aged 6-11 months.
A Single-centre Phase III Clinical Trial for Vero Cell-derived Inactivated Japanese Encephalitis Vaccine Produced by Shandong Hengye Biotech Co., Ltd. in Healthy Chinese Infants Aged 6-11 Months, Aimed to Evaluate Immunogenicity and Safety
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.
100 Clinical Results associated with Shandong Hengye Biotech Co., Ltd.
0 Patents (Medical) associated with Shandong Hengye Biotech Co., Ltd.
100 Deals associated with Shandong Hengye Biotech Co., Ltd.
100 Translational Medicine associated with Shandong Hengye Biotech Co., Ltd.