Sinovac Biotech Ltd. (NASDAQ: SVA) enjoyed slight gains Monday, after the company disclosed preliminary top-line results from PHASE III clinical trial for Varicella vaccine candidate against chickenpox.
The Beijing-based Sinovac, the leading provider of vaccines in China, announced today preliminary top-line data from its Phase III clinical trial assessing the efficacy, immunogenicity and safety of the Company's proprietary Varicella vaccine against Chickenpox.
The primary objective of the study was to evaluate the efficacy of the Varicella vaccine in the prevention of Chickenpox caused by Varicella-Zoster Virus (VZV). The preliminary Phase III data showed that Sinovac's Varicella vaccine was 87.1% efficacious against Chickenpox caused by VZV.
The double-blinded, randomized, placebo controlled Phase III clinical trial was conducted at two sites across China's Henanprovince. Approximately 6,000 healthy children from one to 12 years old completed the one dose vaccination schedule in the August of 2016, prior to the Chickenpox epidemic season in China, followed by an active monitoring period.
The study results showed consistent immune response for all three lots and a good safety profile. With immunogenicconsistency across the three consecutive lots, the results showed that Sinovac's vaccine production process and quality are stable. The production facility of Varicella vaccine has also reached commercial scale.
Sinovac obtained clinical research approval for its proprietary Varicella vaccine candidate from the CFDA in September 2015, and completed Phase I clinical trials last year. The preliminary results of the Phase I studies confirmed that Sinovac's vaccine candidate has a good safety profile.
Shares for Sinovac gained seven cents, or 1%, to $6.97.
