Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385821
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2023-09-04
Brief Title:
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
Sponsor:
NPO Petrovax
Organization:
NPO Petrovax
Study Overview
Official Title:
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
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 140 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
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 140 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None