The phase III clinical trials will assess the efficacy and safety of the CoronaVac vaccine candidate, which is developed by Sinovac Life Sciences.
Sinovac’s case-driven, randomised, double-blinded and placebo-controlled phase III clinical trial adopts an adaptive design and recruits all participants on a step-by-step basis.
The company will enrol 1,300 healthcare workers between the ages of 18-59 years during the first stage. They will be randomised to secure two doses of vaccine or placebo at a two-week interval.
Sinovac will enrol around 12,000 members from the general population between the ages of 18-59 years old during the second stage. The members will secure two doses of vaccine or placebo at a two-week interval.
The firm has conducted phase I/II clinical trials of CoronaVac in adults and elderly volunteers aged between 18 and 59 years in Jiangsu and Hebei provinces of China in April and May this year.
According to the company, the vaccine candidate demonstrated to be well tolerated for different dosage and no serious vaccine-related adverse events have been reported.
Sinovac has also collaborated with several companies outside of China for phase III efficacy studies along with Turkey.
In April this year, Sinovac Biotech received approval in China to proceed with a human clinical trial on an inactivated vaccine candidate against the SARS-CoV-2 virus (novel coronavirus or Covid-19).
Sinovac’s product portfolio comprises vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, Quadrivalent Influenza vaccine (QIV), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps.