NCT05739474

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
948

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

February 13, 2023

Last Update Submit

August 29, 2023

Conditions

InfluenzaInfluenza, HumanInfluenza Viral InfectionsVaccine Reaction

Keywords

InfluenzaFluVaccineVaccinationSPbSRIVSFlu-M Tetra

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (19)

  • 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)

  • 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)

  • 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 immediate adverse events (allergic reactions)

    2 hours after vaccination

  • Incidence of local adverse events

    7 days after vaccination

  • +14 more secondary outcomes

Study Arms (6)

Flu-M Tetra vaccine, children aged 10 to 17 years old

EXPERIMENTAL

Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly

Biological: Influenza vaccine [inactivated]

VaxigripTetra vaccine, children aged 10 to 17 years old

ACTIVE COMPARATOR

Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly

Biological: Influenza vaccine [inactivated]

Flu-M Tetra vaccine, children aged 3 to 9 years old

EXPERIMENTAL

Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before

Biological: Influenza vaccine [inactivated]

VaxigripTetra vaccine, children aged 3 to 9 years old

ACTIVE COMPARATOR

Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before

Biological: Influenza vaccine [inactivated]

Flu-M Tetra vaccine, children aged 6 to 35 months old

EXPERIMENTAL

Сhildren will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine intramuscularly

Biological: Influenza vaccine [inactivated]

VaxigripTetra vaccine, children aged 6 to 35 months old

ACTIVE COMPARATOR

Сhildren will be vaccinated twice 0.25 mL dose of the VaxigripTetra vaccine intramuscularly

Biological: Influenza vaccine [inactivated]

Interventions

Influenza vaccine [inactivated]BIOLOGICAL

solution for intramuscular injection, 1 dose (0.5 mL)

Also known as: Flu-M Tetra Inactivated Split Quadrivalent Influenza Vaccine
Flu-M Tetra vaccine, children aged 10 to 17 years oldFlu-M Tetra vaccine, children aged 3 to 9 years oldFlu-M Tetra vaccine, children aged 6 to 35 months old

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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);
  • The availability of written and dated informed consent of a parent / legally acceptable representative 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:
  • The ability of a volunteer's parents / legally acceptable representatives to perform the requirements of the Protocol (i.e., fill out the Patient Diary, attend visits together 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;
  • 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;
  • 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;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

State Autonomous Health Care Institution "Engels City Clinical Hospital No1"

Engel's, Russia

RECRUITING

Llc "Olla-Med"

Moscow, Russia

RECRUITING

LLC "Professorskaya Clinica"

Perm, Russia

NOT YET RECRUITING

State Budgetary Healthcare Institution of the Perm Territory "City Children's Clinical Clinic No. 5"

Perm, Russia

ACTIVE NOT RECRUITING

LLC PiterClinica

Saint Petersburg, Russia

RECRUITING

LLC "DNA Research Center"

Saratov, Russia

RECRUITING

State Autonomous Health Care Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11"

Yekaterinburg, Russia

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Ellina Ruzanova, PhD

    St. Petersburg Research Institute of Vaccines and Sera

    STUDY DIRECTOR

Central Study Contacts

Ellina Ruzanova, PhD

CONTACT

(812) 660-06-39e.a.ruzanova@niivs.ru

Alla Emelyanova, PhD

CONTACT

(812) 660-06-39a.b.emelyanova@niivs.ru

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

February 13, 2023

First Posted

February 22, 2023

Study Start

January 19, 2022

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

RU(7)