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: 1. 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" 2. Evaluate the immunogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators: * Proportion of those vaccinated with seroconversion and geometric mean titer of antibodies to the fourth additional strain of compared vaccines * 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 * Seroprotection (proportion (%) vaccinated with antibody titer ≥ 1:40 to 4 strains of influenza virus in paired sera of the hemagglutination inhibition reaction after vaccination) 3. Evaluate the effectiveness of the Grippol Quadrivalent vaccine and the Grippol plus vaccine according to the following indicators: * Incidence of Influenza and ARI (Month 1-Month 6 after vaccination) * Severity and duration of reported cases of influenza and ARI, presence of complications 4. Assess the reactogenicity of the Grippol Quadrivalent vaccine and the Grippol plus vaccine in children aged 6 months to 5 years (inclusive): * Frequency and nature of general and local post-vaccination reactions (7-day follow-up period after vaccine administration) 5. Assess the safety of Grippol Quadrivalent and Grippol Plus in children aged 6 months to 5 years (inclusive)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
824
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).
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).
Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky"
Moscow, Russia
State Budgetary Healthcare Institution "Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department"
Moscow, Russia
State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5
Perm, Russia
Limited Liability Company "Clinic USI 4D"
Pyatigorsk, Russia
Limited Liability Company Medical technology
Saint Petersburg, Russia
St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District"
Saint Petersburg, Russia
Limited Liability Company " Energiia Zdoroviya"
Saint Petersburg, Russia
Limited Liability Company PiterClinica
Saint Petersburg, Russia
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency
Saint Petersburg, Russia
St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37
Saint Petersburg, Russia
...and 4 more locations
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: 1. increase in antibody titer to influenza virus strains to ≥ 1:40 (with initial antibody titer \< 1:10); or 2. an increase in antibody titer by 4 or more times compared to the initial titer (with an initial antibody titer ≥ 1:10) in paired sera RTGA after vaccination. 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.
Time frame: Baseline to Day 25±3
Geometric mean antibody titers
Geometric mean antibody titers after vaccination for three matching strains
Time frame: Baseline to Day 25±3
Proportion of those vaccinated with seroconversion and geometric mean titer
Proportion of those vaccinated with seroconversion and geometric mean titer of antibodies to the fourth additional strain of compared vaccines
Time frame: 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
Time frame: 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)
Time frame: Baseline to Day 25±3
Incidence of influenza and acute respiratory infections (ARI)
• Incidence of influenza and ARI (Month 1 - Month 6 after vaccination)
Time frame: 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)
Time frame: 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)
Time frame: First 7 days after vaccination
Frequency and nature of SAEs
Frequency and nature of SAEs (Day 1-Month 6)
Time frame: Baseline to month 6
Frequency and nature of medically attended AEs
Frequency and nature of medically attended AEs (Month 1-Month 6)
Time frame: Baseline to month 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.