Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Tetra Vaccine in Children Between 6 Months and 17 Years Old

St. Petersburg Research Institute of Vaccines and Sera7 sites in 1 country948 target enrollmentJanuary 19, 2022

ConditionsInfluenza Influenza, Human Influenza Viral Infections Vaccine Reaction

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: St. Petersburg Research Institute of Vaccines and Sera
Enrollment: 948
Locations: 7
Primary Endpoint: Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive.

Detailed Description

The trial will be conducted in three stages. • Stage I Participants - children aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days), will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly. Once reviewed by the Sponsor, the report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II trial. • Stage II Participants - children aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days), will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly (double dose for volunteers who have not been vaccinated before). Once reviewed by the Sponsor, the report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage III trial. • Stage III Participants - children aged 6 to 35 months (6 months 0 days - 35 months 30 days), will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly.

Registry

clinicaltrials.gov

Start Date

January 19, 2022

End Date

December 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

St. Petersburg Research Institute of Vaccines and Sera

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For volunteers aged 10 to 17 years:
•Healthy children of both sexes aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days);
•The availability of written and dated informed consent of the volunteer (children aged 14 to 17 years) and their parent / legally acceptable representative for participation in the trial;
•If the volunteer has sexual relations, effective contraception methods must be used during the 30 days preceding vaccination and consent must be obtained to continue using these contraceptive methods during the trial and for two months after vaccination;
•The girls with menses in the medical history shall have a negative pregnancy test result.
•For volunteers aged 3 to 9 years:
•Healthy children of both sexes aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days);
•The availability of written and dated informed consent of a parent / legally acceptable representative for participation in the trial;
•For volunteers aged 6 to 35 months:
•Healthy children of both genders aged 6 to 35 months, inclusive (6 months 0 days - 35 months 30 days);

Exclusion Criteria

•History of influenza (including in mothers for children aged 6 to 35 months) or previous influenza vaccination during 6 months before the trial;
•Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine
•Positive result of the SARS-CoV-2 test;
•Vaccination with any vaccine less than 30 days before participating in the trial or scheduled vaccination with any vaccine within 30 days after vaccination with the trial vaccines;
•A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter at the injection site) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination), encephalopathy;
•Allergic reactions to vaccine components or any previous vaccination;
•History of allergic reaction to chicken protein;
•History of cancer, leukemia, tuberculosis, autoimmune diseases;
•Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents / legally acceptable representatives;
•Children who received immunoglobulin products or transfusions of whole blood or its components less than 3 months before the start of the trial;

Outcomes

Primary Outcomes

Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B)

Time Frame: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)

Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated participants in haemagglutination inhibition assay

Secondary Outcomes

Change from Baseline Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)(Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III))
Incidence of immediate adverse events (allergic reactions)(2 hours after vaccination)
Incidence of local adverse events(7 days after vaccination)
Number of participants with abnormal physical examination findings(Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination))
Number of participants with abnormal changes in vital signs - Blood pressure (BP)(Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination))
Number of participants with abnormal changes in vital signs - Heart rate (HR)(Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination))
Number of participants with clinically significant abnormalities - Urinalysis(Days 1, 3)
Number of participants with abnormal neurological examinations(Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination))
Change from Baseline Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)(Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III))
Number of participants with abnormal changes in vital signs - Respiratory rate (RR)(Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination))
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)(Days 1, 3)
Number of participants with abnormal changes of total IgE(Days 1, 3)
Incidence of systemic adverse events(7 days after vaccination)
Incidence of other adverse reactions(Days 8 to 28 after vaccination)
Number of participants with abnormal changes in vital signs - Body temperature(Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination))
Number of participants with clinically significant abnormalities - Complete blood count (CBC)(Days 1, 3)
Change from Baseline Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)(Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III))
Incidence of severe adverse events(Days 1 to 28+3 (for participants with 1 vaccination), Day 1 to 56±3 (for participants with vaccination and revaccination))
Withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products(Days 1 to 28+3 (for participants with 1 vaccination), Day 1 to 56±3 (for participants with vaccination and revaccination))