A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine

Summary

The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.

Timeline

Start

2012-08

Primary completion

2013-03

Completion

2013-05

Publications

• Cheng A, Hsieh SM, Pan SC, Li YH, Hsieh EF, Lee HC, Lin TW, Lai KL, Chen C, Shi-Chung Chang S, Chang SC. The safety and immunogenicity of a cell-derived adjuvanted H5N1 vaccine - A phase I randomized clinical trial. J Microbiol Immunol Infect. 2019 Oct;52(5):685-692. doi: 10.1016/j.jmii.2019.03.009. Epub 2019 May 18.

Drugs

Indications