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The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) authorized Thursday the Center for Genetic Engineering and Biotechnology (CIGB) to start pediatric clinical trials with the Cuban vaccine candidate Abdala.
An adaptive, randomized, double-blind, parallel-group, double-blind, Phase I/II clinical trial will be conducted to evaluate the safety and immunogenicity, beginning July 5.
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The trials will be carried out with the participation of apparently healthy Cuban children and adolescents, who will be given two doses of the vaccine candidate Abdala with the goal of preventing COVID-19.
Ante el aumento sostenido de pacientes pediátricos se autorizó el inicio del ensayo clínico Ismaelillo-Pediatría a partir del 5 de julio. Previsto a realizarse con 600 voluntarios de tres a 18 años de edad. #MásQueUnaVacunaEsUnPaís por la salud de nuestros niños.#Cuba pic.twitter.com/i5MKUGAxaY
— ꧁Kamila������������ (@CamilaGzlez34) July 2, 2021
"In view of the sustained increase in the number of pediatric patients, the Ismaelillo-Pediatrics clinical trial was authorized to begin on July 5. Planned to be carried out with 600 volunteers between three and 18 years of age."
The trial will include 592 children and adolescents between 3 and 18 years of age on a voluntary basis, with the signature of informed consent by parents or legal guardians, as well as the signature of informed assent for participants older than 12 years of age, residents in health areas of urban zones of the provinicial capital of Camagüey.
This pediatric clinical trial with Abdala has been named "Ismaelillo", recalling José Martí's renowned poem to his son.
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