China-based Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has received clearance from the Directorate General of Drug Administration (DGDA) of Bangladesh to conduct a Phase III clinical study for its bivalent dysentery conjugate vaccine. This vaccine targets Shigella flexneri and Shigella sonnei, the pathogens responsible for bacterial dysentery, an acute intestinal infectious disease.
Vaccine Innovation
The vaccine, developed by Chongqing Zhifei Biological, is the first of its kind globally, with no similar products approved elsewhere. It aims to prevent bacterial dysentery, a significant public health concern, particularly in regions with limited healthcare infrastructure.
Clinical Trial Design
The Phase III study is structured as a randomized, blinded, placebo-controlled trial. It will enroll infants and young children aged 6 months to 5 years to evaluate the vaccine’s efficacy, immunogenicity, and safety. This rigorous design ensures robust data collection to support potential regulatory approval.-Fineline Info & Tech
