(RTTNews) - Sinovac Biotech Ltd. (SVA), a provider of biopharmaceutical products in China, said Tuesday it has recently commenced Phase III clinical trials for its inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences, or "CoronaVac," in Turkey.
The phase III clinical trial seeks to test efficacy and safety of CoronaVac in Turkey and aims to be a pivotal study to support the licensure of this product.
This case-driven, randomized, double-blinded and placebo-controlled phase III clinical trial uses an adaptive design, and all participants will be enrolled in a step-by-step basis.
In the first stage, 1,300 healthcare workers between the ages of 18 and 59 years will be randomly selected to receive two doses of vaccine or placebo at a two-week interval.
In the second stage, about 12,000 members of the general population between the ages of 18 and 59 years will be enrolled to receive two doses of vaccine or placebo at a two-week interval.
Sinovac noted that in recent months, its Phase I/II clinical trials of CoronaVac in adults and elderly volunteers were conducted in China's Jiangsu and Hebei Provinces on April 16th and May 22nd, respectively.
According to the company, the vaccine candidate appeared to be well tolerated for different dosage and no serious vaccine-related adverse events were reported, demonstrating a good safety profile for the vaccine candidate.
In addition to Turkey, Sinovac has partnered with several companies outside of China for phase III efficacy studies.
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