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publicado el 02/10/2021

Clinical trial with Soberana Plus to begin in pediatric population convalescing from Covid-19

Prior to October 5th, the recruitment process for phase I of convalescent children who have been diagnosed with a positive PCR test and have been for at least 2 months after been discharged from hospital.

On October 5th, the clinical trial will begin at the Juan Manuel Márquez Pediatric Hospital in the capital, with the immunogenic Soberana Plus, from the Finlay Vaccine Institute, in the pediatric population convalescent from Covid-19.

Soberana Plus Pediatric will be a Phase I/II open-label, adaptive study to evaluate safety, efficacy and immunogenicity of Soberana Plus in a total of samples of 250 adolescents and children convalescent from Covid -19in the provinces of Havana and Cienfuegos.

The study will start in phase I which will be carried out only at the Juan Manuel Márquez Pediatric Hospital, including 40 subjects (20 from 12 to 18 years of age and 20 from 2 to 11 years of age) with a radio of 10 to 10 per each population group (10 symptomatic patients and 10 asymptomatic), all of them will receive a single dose of Soberana Plus.

Taken from Gramma

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