Sinovac Biotech has initiated human clinical trials for its pandemic flu (H5N1) vaccine Panflu(TM). The vaccine was administered to the first 6 volunteers at the Beijing Sino-Japan Friendship Hospital in Beijing.
Due to this vaccine's mature technology, China's State Food and Drug Administration (SFDA) earlier approved modification to "fast-track" the clinical trial process from 3 phases to only 2 stages.
Stage I includes 120 healthy volunteers, ages 18 – 60 years and is expected to take nine-months. However, preliminary results should be available by the end of March, 2006.
Sinovac partnered with Beijing Sino-Japan Friendship Hospital for the successful Phase I SARS clinical trials in 2004.
Protocols for clinical trials are strictly regulated and include compliance with SFDA's National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), World Health Organization (WHO) "Guidelines on Clinical Evaluation of Vaccines," and other relevant regulations.
The trials will be compliant with Good Clinical Practices (GCP) procedures, including ethical guidelines.
