Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

NCT05470582 | Completed Phase 3

• 1 other identifier: FLM-04-2020
• Study Type: interventional
• Target: 1,066
• Locations: 1 country
• Sites: 2

Brief Summary

Comparative trial of tolerability, reactogenicity, safety and immunogenicity of the Flu-M vaccine as compared to the Vaxigrip® vaccine in terms of prevention of influenza in children aged 6 months to 9 years (at the time of the first vaccination).

Conditions

Influenza, Human; Vaccination; Infection; Vaccines

Keywords

Influenza; Flu; Vaccine; FLU-M; SPbSRIVS; Vaxigrip; Children

Outcome Measures

Primary Outcomes (1)

• Change from Baseline seroconversion level

  Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay) The upper limit of bilateral 95 % CI for the difference between seroconversion levels (seroconversion level reference vaccine - the seroconversion level trial vaccine) should not exceed 10%. Seroconversion ≥ 40%

  Days 0 (screening), 28, 56, 180 after vaccination/revaccination

Secondary Outcomes (18)

• Change from Baseline Geometric mean titer (GMT) of antibodies

  Days 0 (screening), 28 after vaccination/revaccination

• Change from Baseline Seroconversion factor

  Days 0 (screening), 28, 56, 180 after vaccination/revaccination

• Change from Baseline Seroprotection rate

  Days 0 (screening), 28, 56, 180 after vaccination/revaccination

• Change from Baseline Seroconversion rate for each virus strain

  Days 0 (screening), 28, 56, 180 after vaccination/revaccination

• Incidence of immediate adverse events (allergic reactions)

  2 hours after vaccination/revaccination

Study Arms (4)

Flu-M, children aged 3-9 years

EXPERIMENTAL

Biological: Flu-M, Inactivated split influenza vaccine 0.5 mL

Vaxigrip, children aged 3-9 years

ACTIVE COMPARATOR

Biological: Vaxigrip, Inactivated split influenza vaccine 0.5 mL

Flu-M, children aged 6-35 months

EXPERIMENTAL

Biological: Flu-M, Inactivated split influenza vaccine 0.25 mL

Vaxigrip, children aged 6-35 months

ACTIVE COMPARATOR

Biological: Vaxigrip, Inactivated split influenza vaccine 0.25 mL

Interventions

Flu-M, Inactivated split influenza vaccine 0.5 mL BIOLOGICAL

Solution for intramuscular injection Сhildren were vaccinated with the Flu-M vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL

Flu-M, children aged 3-9 years

Vaxigrip, Inactivated split influenza vaccine 0.5 mL BIOLOGICAL

Suspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL

Vaxigrip, children aged 3-9 years

Flu-M, Inactivated split influenza vaccine 0.25 mL BIOLOGICAL

Solution for intramuscular injection Children were vaccinated with the Flu-M vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL

Flu-M, children aged 6-35 months

Vaxigrip, Inactivated split influenza vaccine 0.25 mL BIOLOGICAL

Suspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL

Vaxigrip, children aged 6-35 months

Eligibility Criteria

• Age: 6 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For volunteers aged 3 to 9 years:
• Healthy children of both sexes aged 3 to 9 years (3 years 0 months 0 days - 8 years 11 months 30 days);
• The written and dated informed consent of one of the parents 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);
• The written and dated informed consent of one of the parents for participation in the trial;
• The trial subject of the was born full-term, with the Apgar score of 7-10 points.
• For all volunteers:
• Ability of a volunteer's parents to fulfill the requirements of the Protocol (i.e. to fill out the Patient Diary, come to visit with the volunteer).

You may not qualify if:

• History of influenza (including in mothers for children aged 6 to 35 months) or previous influenza vaccination during 6 months before the trial;
• Positive result of the SARS-CoV-2 test;
• Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine;
• 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;
• Children who received immunoglobulin products or transfusions of whole blood or its components less than 3 months before the start of the trial;
• Long-term use (more than 14 days) of any immunomodulating medicines less than 3 months before the start of the trial;
• Any confirmed or suspected immunosuppressive or immunodeficiency condition;
• History of chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, blood in the acute stage (recovery less than 4 weeks before vaccination) or in the decompensation stage;
• Children with hemophilia who may develop bleeding after intramuscular injection;
• History of progressive neurological pathology, convulsive syndrome, afebrile convulsions;

Sponsors & Collaborators

• St. Petersburg Research Institute of Vaccines and Sera: lead

Study Sites (2)

LLC "Energiya zdorov'ya"

Saint Petersburg, Russia

Location

St. Petersburg State Budgetary Institution of Health Care "Children's City Polyclinic No. 45" of the Nevsky District

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Influenza, Human; Infections

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Ellina Ruzanova, PhD

  St. Petersburg Research Institute of Vaccines and Sera

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 22, 2022
• Study Start: February 16, 2021
• Primary Completion: October 29, 2021
• Study Completion: December 24, 2021
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

RU (2)