Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

Phase 4 Completed 612 enrolled Xiamen Innovax Biotech Co., Ltd Center for Disease Control and Prevention, Fujian · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli) when administered in participants ages 16 years and above.

Timeline

Start: 2023-03-22
Primary completion: 2024-03-28
Completion: 2024-03-28

Publications

Li J, Wang X, Zhang D, Xie F, Zhong S, Yu X, Chen S, Huang Q, Wang R, Zhang Q, Zhang D. Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study. Vaccine. 2025 Aug 30;62:127510. doi: 10.1016/j.vaccine.2025.127510. Epub 2025 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Hecolin®	Vaccine	—	Intramuscular
Subject	Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)	Vaccine	—	Intramuscular

Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

Summary

Timeline

Publications

Drugs

Indications