The study of the Cuban anti-COVID candidate vaccine will include 350 children and adolescents, 50 in Phase I and 300 in Phase II, conducted in an overlapping and gradual process, in strict compliance with protocols and best practices
Following verification of the candidate’s safety in a group of adolescents aged 12 to 18, clinical trials of Soberana-Pediatria continue with the inclusion of a second group of volunteers in the three to 11 age group, Yury Valdes Balbin, assistant director of the Finlay Vaccine Institute, reported.
The results of the security investigation revealed no adverse side effects, thus allowing for younger children to be included and the group of volunteers expanded to 150.
Specialists at the Finlay Institute explained that this is an open study with no placebos administered, and also adaptive, meaning that modifications can be made, if elements appear that indicate a change in the study’s design.
The trials will be conducted at several sites, with the first phase at Juan Manuel Marquez Pediatric Hospital and the second at the primary care level, involving several community polyclinics.
The study of the Cuban anti-COVID candidate vaccine will eventually include 350 children and adolescents, 50 in Phase I and 300 in Phase II, conducted in an overlapping and gradual process of three doses, in strict compliance with protocol and best practices.
(Taken from Granma)