drugset / Trial / NCT05739474

Tolerability, Safety and Immunogenicity Trial of the Flu-M Tetra Vaccine in Children

NCT05739474

RandomizedParallel-groupDouble-blindPrevention

Summary

The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive.

Timeline

Start
2022-01-19
Primary completion
2023-06-30
Completion
2023-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Flu-M Tetra Vaccine 0.25 ml Intramuscular
Subject Flu-M Tetra Vaccine 0.5 ml Intramuscular
Subject NITRAMINE Vaccine 0.25 ml Intramuscular
Subject NITRAMINE Vaccine 0.5 ml Intramuscular

Indications