Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

Summary

Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008. In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.

Timeline

Start

2008-12

Primary completion

2009-01

Completion

2009-03

Publications

• Results Zhang PR, Zhu XP, Zhou LJ, Liu YQ, Fan Y, Chen G, Chen Z, Liu Y, Sun HY, Wu JL. [Safety and immunological effect of domestic split influenza virus vaccine]. Zhonghua Yu Fang Yi Xue Za Zhi. 2009 Jul;43(7):615-8. Chinese.

Drugs

Indications