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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".
The main questions it aims to answer are:
To compare the 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 "geometric mean antibody titers after vaccination"
Evaluate the immunogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators:
Evaluate the effectiveness of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators:
Assess the reactogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine in children aged 6 months to 5 years (inclusive):
Assess the safety of Grippol Quadrivalent and Grippol Plus in children aged 6 months to 5 years (inclusive)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grippol Quadrivalent | Experimental | influenza quadrivalent inactivated subunit adjuvant vaccine |
|
| Grippol Plus | Active Comparator | influenza trivalent inactivated polymer-subunit vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grippol Quadrivalent | Biological | Solution for intramuscular and subcutaneous administration, 0.5 ml/dose. Children from 36 months to 5 years - in the upper third of the outer surface of the shoulder intramuscularly (in the deltoid muscle) at a dose of 0.5 ml once (Day 1). Children from 6 to 35 months - in the anterolateral surface of the thigh intramuscularly 0.25 ml twice with an interval of 3-4 weeks (Day 1, Day 25±3). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Proportion of vaccinated seroconverters in paired hemagglutination inhibition test sera obtained before and after vaccination Seroconversion is defined as:
The initial antibody titer will be the titers of antibodies to influenza virus antigens in the hemagglutination inhibition reaction obtained during screening. Post-vaccination titres will be those obtained on Day 25±3 after a single dose of vaccine in children 36 months to 5 years of age or a second dose of vaccine in children 6 to 35 months of age. | Baseline to Day 25±3 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean antibody titers | Geometric mean antibody titers after vaccination for three matching strains | Baseline to Day 25±3 |
| Proportion of those vaccinated with seroconversion and geometric mean titer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky" | Moscow | 119435 | Russia |
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|
| Grippol Plus | Biological | Suspension for intramuscular and subcutaneous administration, 0.5 ml/dose. Children from 36 months to 5 years - in the upper third of the outer surface of the shoulder intramuscularly (in the deltoid muscle) at a dose of 0.5 ml once (Day 1). Children from 6 to 35 months - in the anterolateral surface of the thigh intramuscularly, 0.25 ml twice with an interval of 3-4 weeks (Day 1, Day 25±3). |
|
Proportion of those vaccinated with seroconversion and geometric mean titer of antibodies to the fourth additional strain of compared vaccines
| Baseline to Day 25±3 |
| Multiplicity of the increase in the geometric mean titer | Multiplicity of the increase in the geometric mean titer of antibodies to 4 strains of the influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination in relation to the initial values of antibody titers | Baseline to Day 25±3 |
| Seroprotection | Seroprotection (proportion (%) vaccinated with antibody titer ≥ 1:40 to 4 strains of influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination) | Baseline to Day 25±3 |
| Incidence of influenza and acute respiratory infections (ARI) | • Incidence of influenza and ARI (Month 1 - Month 6 after vaccination) | Month 1-6 |
| The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications | The severity and duration of registered cases of influenza and ARI, the presence of complications (Month 1 - Month 6 after vaccination) | Month 1 to Month 6 |
| To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus | Frequency and nature of general and local post-vaccination reactions (7-day follow-up period after vaccine administration) | First 7 days after vaccination |
| Frequency and nature of SAEs | Frequency and nature of SAEs (Day 1-Month 6) | Baseline to month 6 |
| Frequency and nature of medically attended AEs | Frequency and nature of medically attended AEs (Month 1-Month 6) | Baseline to month 6 |
| State Budgetary Healthcare Institution "Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department" | Moscow | 123317 | Russia |
| State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5 | Perm | 614066 | Russia |
| Limited Liability Company "Clinic USI 4D" | Pyatigorsk | 357502 | Russia |
| Limited Liability Company Medical technology | Saint Petersburg | 192148 | Russia |
| St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District" | Saint Petersburg | 193312 | Russia |
| Limited Liability Company " Energiia Zdoroviya" | Saint Petersburg | 194156 | Russia |
| Limited Liability Company PiterClinica | Saint Petersburg | 196158 | Russia |
| Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency | Saint Petersburg | 197022 | Russia |
| St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37 | Saint Petersburg | 198328 | Russia |
| State Budgetary Healthcare Institution of the Samara region "Samara Regional Children's Clinical Hospital named after N.N. Ivanova" | Samara | 443079 | Russia |
| Limited Liability Company Center DNK-issledovaniy | Saratov | 410005 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" of the Ministry of Healthcare of the Russian Federation | Tyumen | 625023 | Russia |
| State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11" | Yekaterinburg | 620028 | Russia |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C408342 | Grippol |
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