Clinical Trial of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells)

Summary

This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases. Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 （D28）.

Timeline

Start

2023-08

Primary completion

2024-04

Completion

2024-12

Drugs

Indications