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

Exclusion Criteria

• •1. History of influenza (including in mothers for children aged 6 to 35 months) or previous influenza vaccination during 6 months before the trial;
• •2. Positive result of the SARS-CoV-2 test;
• •3. Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine;
• •4. Vaccination with any vaccine less than 30 days before participating in the trial or scheduled vaccination with any vaccine within 30 days after vaccination with the trial vaccines;
• •5. A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter at the injection site) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination), encephalopathy;
• •6. Allergic reactions to vaccine components or any previous vaccination;
• •7. History of allergic reaction to chicken protein;
• •8. History of cancer, leukemia, tuberculosis, autoimmune diseases;
• •9. Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents;
• •10. Children who received immunoglobulin products or transfusions of whole blood or its components less than 3 months before the start of the trial;
• •11. Long-term use (more than 14 days) of any immunomodulating medicines less than 3 months before the start of the trial;
• •12. Any confirmed or suspected immunosuppressive or immunodeficiency condition;
• •13. History of chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, blood in the acute stage (recovery less than 4 weeks before vaccination) or in the decompensation stage;
• •14. Children with hemophilia who may develop bleeding after intramuscular injection;
• •15. History of progressive neurological pathology, convulsive syndrome, afebrile convulsions;
• •16. History of acute infectious diseases (fever ≥ 37.5°С): recovery less than 2 weeks before vaccination;
• •17. Participation in another clinical trial less than 3 months before the start of the trial;
• •18. History of mental illness of the child and the volunteer's parents;
• •19. The history of the volunteer's parent being registered with a tuberculosis dispensary and/or a narcological dispensary;
• •20. Maternal history of drug use or alcohol abuse during pregnancy and/or breastfeeding;
• •21. Pronounced congenital malformations in a child;
• •22. Suspected developmental delay in a child.