The vaccination is part of the continued research for Sinovac’s Phase I clinical trial of whole viron H5N1 vaccine and the beginning of its Phase I clinical trial of split H5N1 vaccine.
Phase II clinical trials for the H5N1 vaccine were approved in April 2007 by the China State Food and Drug Administration (SFDA). The SFDA approval covers a Phase Ib and II trials of whole viron vaccine and Phase I and II trials of split vaccine. Subsequent to these approvals, the preparation work was completed by the end of July 2007.
These clinical trials will be open label and will assess the tolerance and safety of the vaccine. The company anticipates that the Phase II trials will commence shortly and the preliminary results from these clinical trials for both vaccines will be available early next year.
Sinovac said that, in June 2006, the Phase I clinical trial of a pandemic influenza whole viron inactivated vaccine for H5N1 was successfully completed. The vaccine was co-developed by Sinovac Biotech and the Chinese CDC.