Sinovac Initiates Phase II Clinical Trial On Pandemic Influenza H5N1 Vaccine
Pandemic Influenza H5N1 Vaccine
Sinovac Biotech has commenced vaccination of volunteers for its Phase II clinical research study of its pandemic influenza H5N1 vaccine.
The Phase II clinical trial is a randomized double-blind study to assess the safety and efficacy of the pandemic influenza H5N1 vaccine. The trial started with 400 adult volunteers vaccinated with Pandemic Influenza whole viron H5N1 Vaccine. The initial result from this study is expected to be available by the end of 2007.
As previously announced, Phase II clinical trial for the H5N1 vaccine were approved in April 2007 by the China State Food and Drug Administration (SFDA). The SFDA approval covers Phase Ib and II trials of the whole viron vaccine and Phase I and II trials of the split vaccine.
Phase Ib clinical trial with whole viron H5N1 vaccine and Phase I clinical trial with split H5N1 vaccine commenced in August 2007. The Company is making good progress on these trials.