The clinical trials were initiated in the Huai Rou district, Beijing City on July 22, 2009, with the design of single center, randomization and double blindness. The inoculation was completed on August 15, 2009. A total of 1,614 participants over 3 years old received the H1N1 vaccine. Blood samples were collected from the participants on the vaccination date, 14 days post vaccination date and 21 days post vaccination date. The National Institute for the Control of Pharmaceutical and Biological Products (NICBPB), the central laboratory of China State Food and Drug Administration (SFDA), have completed the HI antibody tests on all blood samples.

This clinical trial was organized by China's Center for Disease Control (CDC), and undertaken by the Beijing CDC. The Ministry of Health (MOH) and the SFDA are continuing to closely monitor this clinical trial. Deputy Director General of MOH Disease Control Department Donglou Xiao, Director of SFDA Registration Section Wei Zhang, and other relevant experts visited the clinical site to inspect the clinical study.

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