Ongoing Study blog
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated (CoronaVac®) in Children and Adolescents Aged 6 months to 17 Years
This phase III clinical trial was designed as a multi-center, case driven, randomized, double-blinded, and placebo-controlled study. The study aims to evaluate the efficacy, safety, and immunogenicity of CoronaVac® in children and adolescents aged 6 months to 17 Years. The study vaccine, CoronaVac®, was developed by Sinovac. A total of 14,000 healthy participants from South Africa, Malaysia, the Philippines, and Chile were enrolled into the trial.
Numolux Group, in partnership with Sinovac, is leading this pivotal study in South Africa. A total of 4503 participants were enrolled across 11 clinical trial sites in the country. Trial sites are located in Gauteng, Northwest Province and the Western Cape. Due to the prevalence of variant strains and the immune persistence of CoronaVac®, a booster dose is being introduced into this study. The immunogenicity of the booster vaccination will be evaluated in this phase of the study. The booster phase will be conducted on a subset of eligible participants. The remaining participants will be unblinded and offered the open label vaccine. The booster phase will begin in October 2022.
