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Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

Influenza, Human Clinical Trial

Official title:
Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

Clinical Trial Summary

Comparative trial of tolerability, reactogenicity, safety and immunogenicity of the Flu-M vaccine as compared to the Vaxigrip® vaccine in terms of prevention of influenza in children aged 6 months to 9 years (at the time of the first vaccination).

Clinical Trial Description

The trial includes 2 stages (stage I, II). At stage I children aged 3-9 years will be included. Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Vaxigrip® vaccine for the first 7 days after vaccination of volunteers during Stage I, an intermediate report will be prepared. The report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II of the trial - the continuation of trial on children aged 3-9 years and the commencement of trial on children aged between 6 months and 35 months. During Stage II, the trial for Stage I volunteers will continue in full and also children aged between 6 and 35 months will be included in the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05470582
Study type Interventional
Source St. Petersburg Research Institute of Vaccines and Sera
Contact
Status Completed
Phase Phase 3
Start date February 16, 2021
Completion date December 24, 2021
View Details
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