According to the state register of permits for drug trials, N. F. Gamaleya National Research Center for Epidemiology and Microbiology has received permission to conduct phase I-III clinical trials of Sputnik M, a coronavirus vaccine for children.
“The purpose of the clinical trial is to assess the safety, tolerability and immunogenicity of Gam-COVID-Vac M, a combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus in children,” the document says.
The vaccine is to be administered to children intramuscularly, in two shots. According to the registry, 2,200 patients are going to participate in the trial. According to the plan, it will be completed on December 31, 2023.
As it became known earlier, more than half of the participants (more than 1,500 people) of the trial aimed at evaluating the safety and effectiveness of Sputnik M vaccine against coronavirus for adolescents have already been administered the first component. They did not have any serious adverse reactions after vaccination.