nctId: NCT06385821 id: GriQv-ch-III-22 briefTitle: A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus overallStatus: COMPLETED date: 2022-09-21 date: 2023-06-15 date: 2023-10-09 date: 2024-04-26 date: 2024-04-26 name: NPO Petrovax class: INDUSTRY briefSummary: The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination". conditions: Influenza conditions: Influenza A conditions: Influenza, Human conditions: Influenza Type B conditions: Flu conditions: Influenza A H3N2 conditions: Influenza A H1N1 conditions: Influenza Epidemic conditions: Flu, Human conditions: Acute Respiratory Infection conditions: Vaccine Reaction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 824 type: ACTUAL name: Grippol Quadrivalent name: Grippol Plus measure: To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines measure: Geometric mean antibody titers measure: Proportion of those vaccinated with seroconversion and geometric mean titer measure: Multiplicity of the increase in the geometric mean titer measure: Seroprotection measure: Incidence of influenza and acute respiratory infections (ARI) measure: The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications measure: To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus measure: Frequency and nature of SAEs measure: Frequency and nature of medically attended AEs sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD facility: State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11" city: Ekaterinburg zip: 620028 country: Russian Federation lat: 56.8519 lon: 60.6122 facility: Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky" city: Moscow zip: 119435 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Healthcare Institution "Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department" city: Moscow zip: 123317 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5 city: Perm zip: 614066 country: Russian Federation lat: 58.01046 lon: 56.25017 facility: Limited Liability Company "Clinic USI 4D" city: Pyatigorsk zip: 357502 country: Russian Federation lat: 44.04861 lon: 43.05944 facility: Limited Liability Company Medical technology city: Saint Petersburg zip: 192148 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District" city: Saint Petersburg zip: 193312 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Limited Liability Company " Energiia Zdoroviya" city: Saint Petersburg zip: 194156 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Limited Liability Company PiterClinica city: Saint Petersburg zip: 196158 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency city: Saint Petersburg zip: 197022 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37 city: Saint Petersburg zip: 198328 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: State Budgetary Healthcare Institution of the Samara region "Samara Regional Children's Clinical Hospital named after N.N. Ivanova" city: Samara zip: 443079 country: Russian Federation lat: 53.20007 lon: 50.15 facility: Limited Liability Company Center DNK-issledovaniy city: Saratov zip: 410005 country: Russian Federation lat: 51.54056 lon: 46.00861 facility: Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" of the Ministry of Healthcare of the Russian Federation city: Tyumen zip: 625023 country: Russian Federation lat: 57.15222 lon: 65.52722 hasResults: False