| First Clinical H1N1 Trials Completed in China |
| 2009/09/10 |
SINOVAC BIOTECH CO.,LTD. announced on August 18, 2009 that it has completed the clinical trials of its H1N1 vaccine. Preliminary results show that the vaccine is both safe and effective to humans, and further analysis indicate that one injection of the vaccine is able produce a fine immune response, with a range of indicators, including positive expression of protective antibodies and antibody turning into positive expression, reaching the desired targets, implying that vaccination can protect human body from being infected by the virus.
Kicked off on July 22, 2009 in Huairou District, Beijing, the clinical trial is designed with mono-center and randomized double-blind control schemes. Vaccination was completed on August 15, with 1,614 volunteers above 3 years of age being injected with the vaccine. Their blood samples were taken and examined at an interval of 0, 14, and 21 days. National Institute for the Control of Pharmaceutical and Biological Products completed the test of HI antibodies. Test results show that one injection of the vaccine has produced no serious adverse reactions either locally or wholly. Adverse reactions reported are mainly transient in nature, showing pains at the injection site. The overall occurrence of adverse reaction is similar to the vaccines for seasonal flu, indicating the fine safety of new vaccine.
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