Tolerability, Safety and Immunogenicity Trial of the Flu-M Tetra Vaccine in Children

Last updated: August 29, 2023
Sponsor: St. Petersburg Research Institute of Vaccines and Sera
Overall Status: Active - Recruiting

Phase

3

Condition

Influenza

Treatment

Influenza vaccine [inactivated]

Clinical Study ID

NCT05739474
FLМ-ТЕ-05-2021
  • Ages 6-17
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 - 17years 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 participationin the trial;
  • If the volunteer has sexual relations, effective contraception methods must be usedduring the 30 days preceding vaccination and consent must be obtained to continueusing these contraceptive methods during the trial and for two months aftervaccination;
  • The girls with menses in the medical history shall have a negative pregnancy testresult. 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 11months 30 days);
  • The availability of written and dated informed consent of a parent / legallyacceptable 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 - 35months 30 days);
  • The availability of written and dated informed consent of a parent / legallyacceptable 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 therequirements of the Protocol (i.e., fill out the Patient Diary, attend visits together withthe volunteer).

Exclusion

Exclusion Criteria:

  1. History of influenza (including in mothers for children aged 6 to 35 months) orprevious influenza vaccination during 6 months before the trial;
  2. Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine
  3. Positive result of the SARS-CoV-2 test;
  4. Vaccination with any vaccine less than 30 days before participating in the trial orscheduled vaccination with any vaccine within 30 days after vaccination with the trialvaccines;
  5. A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema morethan 8 cm in diameter at the injection site) or complications (collapse or shock-likecondition that developed within 48 hours after vaccination; convulsions accompanied ornot accompanied by a fever due to any previous vaccination), encephalopathy;
  6. Allergic reactions to vaccine components or any previous vaccination;
  7. History of allergic reaction to chicken protein;
  8. History of cancer, leukemia, tuberculosis, autoimmune diseases;
  9. Carriage of HIV, syphilis, hepatitis B and C in the medical history, including byparents / legally acceptable representatives;
  10. Children who received immunoglobulin products or transfusions of whole blood or itscomponents less than 3 months before the start of the trial;
  11. Long-term use (more than 14 days) of any immunomodulating medicines less than 3 monthsbefore the start of the trial;
  12. Any confirmed or suspected immunosuppressive or immunodeficiency condition;
  13. History of chronic diseases of the cardiovascular, bronchopulmonary, endocrinesystems, blood in the acute stage (recovery less than 4 weeks before vaccination) orin the decompensation stage;
  14. Children with hemophilia who may develop bleeding after intramuscular injection;
  15. History of progressive neurological pathology, convulsive syndrome, afebrileconvulsions;
  16. History of acute infectious diseases (fever ≥ 37.5°С): recovery less than 2 weeksbefore vaccination;
  17. Participation in another clinical trial less than 3 months before the start of thetrial;
  18. History of mental illness of the child and the volunteer's parents;
  19. The history of the volunteer's parent / legally acceptable representative beingregistered with a tuberculosis dispensary and/or a narcological dispensary;
  20. Maternal history of drug use or alcohol abuse during pregnancy and/or breastfeeding;
  21. Pronounced congenital malformations in a child;
  22. Suspected developmental delay in a child.

Study Design

Total Participants: 948
Treatment Group(s): 1
Primary Treatment: Influenza vaccine [inactivated]
Phase: 3
Study Start date:
January 19, 2022
Estimated Completion Date:
December 30, 2023

Study 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.

Connect with a study center

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

    Ekaterinburg,
    Russian Federation

    Site Not Available

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

    Engel's,
    Russian Federation

    Active - Recruiting

  • Llc "Olla-Med"

    Moscow,
    Russian Federation

    Active - Recruiting

  • LLC "Professorskaya Clinica"

    Perm,
    Russian Federation

    Site Not Available

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

    Perm,
    Russian Federation

    Site Not Available

  • LLC PiterClinica

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • LLC "DNA Research Center"

    Saratov,
    Russian Federation

    Active - Recruiting

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