NCT06385821

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

Multicenter, Double-blind, Randomized, Parallel Group Study to Evaluate the Immunogenicity, Reactogenicity and Safety of the Grippol® Quadrivalent Vaccine in Children Aged 6 Months to 5 Years (Inclusive)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 824 (actual)
• Sponsor: NPO Petrovax · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Accepted

Summary

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".

Detailed description

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)

Conditions

• Influenza
• Influenza A
• Influenza, Human
• Influenza Type B
• Flu
• Influenza A H3N2
• Influenza A H1N1
• Influenza Epidemic
• Flu, Human
• Acute Respiratory Infection
• Vaccine Reaction

Interventions

Type	Name	Description
BIOLOGICAL	Grippol Quadrivalent	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).
BIOLOGICAL	Grippol Plus	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).

Timeline

• Start date: 2022-09-21
• Primary completion: 2023-06-15
• Completion: 2023-10-09
• First posted: 2024-04-26
• Last updated: 2024-04-26

Locations

14 sites across 1 country: Russia