At Stage I of the trial, it is planned to screen not more than 350 children aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days), of which it is planned to include and randomize 300 children meeting the inclusion and non-inclusion criteria.~Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Ultrix® vaccine in the first 7 days after the vaccination of volunteers, during Phase I, an Opinion on Tolerability and Safety Assessment for the Flu-M Vaccine vs. the Ultrix® Vaccine Involving Children Aged 12-17 Years (12 Years 0 Months 0 Days - 17 Years 11 Months 30 Days) will be prepared/~During Phase II , the trial for Phase I volunteers will continue in full in accordance with the Clinical Trial Regulations.~During the trial, not more than 350 children aged between 6 - 11 years (6 years 0 months - 0 days - 11 years 11 months 30 days) will be further screened, of which it is planned to include and randomize 300 children meeting the inclusion criteria and not falling under the non-inclusion criteria.
Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years.