protocolSection identificationModule nctId: NCT06385821, orgStudyIdInfo id: GriQv-ch-III-22, briefTitle: A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-21, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2023-10-09, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: NPO Petrovax, class: INDUSTRY, descriptionModule 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"., conditionsModule 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, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 824, type: ACTUAL, armsInterventionsModule interventions name: Grippol Quadrivalent, interventions name: Grippol Plus, outcomesModule primaryOutcomes 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, secondaryOutcomes measure: Geometric mean antibody titers, secondaryOutcomes measure: Proportion of those vaccinated with seroconversion and geometric mean titer, secondaryOutcomes measure: Multiplicity of the increase in the geometric mean titer, secondaryOutcomes measure: Seroprotection, secondaryOutcomes measure: Incidence of influenza and acute respiratory infections (ARI), secondaryOutcomes measure: The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications, secondaryOutcomes measure: To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus, secondaryOutcomes measure: Frequency and nature of SAEs, secondaryOutcomes measure: Frequency and nature of medically attended AEs, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11", city: Ekaterinburg, zip: 620028, country: Russian Federation, geoPoint lat: 56.8519, lon: 60.6122, locations facility: Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky", city: Moscow, zip: 119435, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations 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, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5, city: Perm, zip: 614066, country: Russian Federation, geoPoint lat: 58.01046, lon: 56.25017, locations facility: Limited Liability Company "Clinic USI 4D", city: Pyatigorsk, zip: 357502, country: Russian Federation, geoPoint lat: 44.04861, lon: 43.05944, locations facility: Limited Liability Company Medical technology, city: Saint Petersburg, zip: 192148, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations 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, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Limited Liability Company " Energiia Zdoroviya", city: Saint Petersburg, zip: 194156, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Limited Liability Company PiterClinica, city: Saint Petersburg, zip: 196158, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations 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, geoPoint lat: 59.93863, lon: 30.31413, locations 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, geoPoint lat: 59.93863, lon: 30.31413, locations 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, geoPoint lat: 53.20007, lon: 50.15, locations facility: Limited Liability Company Center DNK-issledovaniy, city: Saratov, zip: 410005, country: Russian Federation, geoPoint lat: 51.54056, lon: 46.00861, locations 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, geoPoint lat: 57.15222, lon: 65.52722, hasResults: False