A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus

Exclusion Criteria

• •1. Vaccination with any influenza vaccine within the previous 6 months. Vaccination with other vaccines, according to the national vaccination schedule, is allowed no later than 30 days before the introduction of the study vaccine, and no earlier than 30 days after the administration of the study vaccines.
• •2. Participation in a clinical trial of a vaccine, medicinal product, or medical device less than 30 days prior to screening.
• •3. Hypersensitivity to any of the components of the studied vaccines or severe post-vaccination complications to any vaccine in history.
• •4. The presence at the time of screening of acute infectious diseases of any localization, or the presence of a history of acute infectious and non-infectious diseases less than 14 days before screening.
• •5. Body temperature in the armpit ≥37.0°C at screening or before the introduction of the vaccine.
• •6. History of significant chronic diseases, such as malignant neoplasms or blood diseases, autoimmune diseases, insulin-dependent diabetes mellitus, chronic diseases of the lungs, liver or kidneys, cardiovascular, nervous systems, secondary, primary and induced immunodeficiency, HIV- infections, as well as other significant, according to the researcher, diseases.
• •7. A history of seizures or a progressive neurological disease.
• •8. History of Guillain-Barré syndrome (post-infectious demyelinating polyradiculoneuropathy of autoimmune etiology).
• •9. Use of antipyretics, including non-steroidal anti-inflammatory drugs less than 24 hours before screening and vaccination; antibacterial drugs of systemic action - less than 72 hours before screening and vaccination; anticoagulants - less than 3 weeks before screening and vaccination; immunoglobulins, blood products - less than 3 months before screening and vaccination; long-term use of systemic corticosteroids (prednisolone or equivalent for more than 2 consecutive weeks) - less than 3 months before vaccination screening.
• •10. Surgery performed less than 3 months prior to screening.
• •11. Children of research team members or research facility staff involved in this clinical trial.
• •12. Orphans, children left without parental care.
• •13. Any other medical or social condition that, in the opinion of the investigator, precludes the participation of the child in this study.