Official Title
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
Brief Summary

The goal of this clinical trial is to assess tolerability, reactogenicity, safety andimmunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine interms 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.

Recruiting
Influenza
Influenza, Human
Influenza Viral Infections
Vaccine Reaction

Biological: Influenza vaccine [inactivated]

solution for intramuscular injection, 1 dose (0.5 mL)
Other Name: Flu-M Tetra Inactivated Split Quadrivalent Influenza Vaccine

Biological: Influenza vaccine [inactivated]

suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL)
Other Name: VaxigripTetra (inactivated split influenza vaccine)

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);

- 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).

Exclusion Criteria:

1. History of influenza (including in mothers for children aged 6 to 35 months) or
previous 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 or
scheduled vaccination with any vaccine within 30 days after vaccination with the
trial vaccines;

5. 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;

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 by
parents / legally acceptable representatives;

10. Children who received immunoglobulin products or transfusions of whole blood or its
components 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
months before the start of the trial;

12. Any confirmed or suspected immunosuppressive or immunodeficiency condition;

13. 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;

14. Children with hemophilia who may develop bleeding after intramuscular injection;

15. History of progressive neurological pathology, convulsive syndrome, afebrile
convulsions;

16. History of acute infectious diseases (fever ≥ 37.5°С): recovery less than 2 weeks
before vaccination;

17. Participation in another clinical trial less than 3 months before the start of the
trial;

18. History of mental illness of the child and the volunteer's parents;

19. The history of the volunteer's parent / legally acceptable representative being
registered 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.

Eligibility Gender
All
Eligibility Age
Minimum: 6 Months ~ Maximum: 17 Years
Countries
Russian Federation
Locations

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

State Autonomous Health Care Institution "Engels City Clinical Hospital No1"
Engel's, Russian Federation

Llc "Olla-Med"
Moscow, Russian Federation

LLC "Professorskaya Clinica"
Perm, Russian Federation

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

LLC PiterClinica
Saint Petersburg, Russian Federation

LLC "DNA Research Center"
Saratov, Russian Federation

Contacts

Ellina Ruzanova, PhD
(812) 660-06-39
e.a.ruzanova@niivs.ru

Alla Emelyanova, PhD
(812) 660-06-39
a.b.emelyanova@niivs.ru

Ellina Ruzanova, PhD, Study Director
St. Petersburg Research Institute of Vaccines and Sera

St. Petersburg Research Institute of Vaccines and Sera
NCT Number
Keywords
Influenza
Flu
Vaccine
Vaccination
SPbSRIVS
Flu-M Tetra
MeSH Terms
Influenza, Human
Virus Diseases
Vaccines