This Monday, Cuba begins the Soberana-Pediatrics clinical trial with children aged between 3 and 11 years
The Soberana-Pediatrics clinical trial recently started in Cuba with children and adolescents continues this week with the inclusion of the second group of volunteers with ages between 3 and 11 years.
This step takes place after the first 25 adolescents aged 12-18 received the first dose without complications.
According to Yury Valdés Balbín, deputy director of the Finlay Vaccine Institute (IFV), 24, 48, and 72 hours and one week after immunization, the safety of the volunteers was evaluated and no serious adverse events were reported.
These results made it possible for the trial executives to request the Center for the State Control of Medicines, Equipment, and Medical Devices (CECMED) the approval for the inclusion of younger volunteers. Consequently, Soberana 02 will be administered this Monday to 25 selected subjects.
The results obtained with adolescents not only allows to expand the study to younger ages but also to include another 150 children between 12 and 18 years of age, a process that will also begin this week, added Valdés.
Finlay Institute specialists explained that this is an open study because it will not use a placebo. All those involved will receive the vaccine candidates.
(With information from RHC).