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

NCT ID: NCT05739474

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 948 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2023-12-30

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.

Conditions

Influenza; Influenza, Human; Influenza Viral Infections; Vaccine Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 1 dose (0.5 mL)

VaxigripTetra vaccine, children aged 10 to 17 years old

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

Group Type: ACTIVE_COMPARATOR

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL)

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

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

Group Type: EXPERIMENTAL

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 1 dose (0.5 mL)

VaxigripTetra vaccine, children aged 3 to 9 years old

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

Group Type: ACTIVE_COMPARATOR

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL)

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

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

Group Type: EXPERIMENTAL

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 1 dose (0.5 mL)

VaxigripTetra vaccine, children aged 6 to 35 months old

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

Group Type: ACTIVE_COMPARATOR

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL)

Interventions

Influenza vaccine [inactivated]

solution for intramuscular injection, 1 dose (0.5 mL)

Intervention Type: BIOLOGICAL

Influenza vaccine [inactivated]

suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL)

Intervention Type: BIOLOGICAL

Other Intervention Names

Flu-M Tetra Inactivated Split Quadrivalent Influenza Vaccine; 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Petersburg Research Institute of Vaccines and Sera

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellina Ruzanova, PhD

Role: STUDY_DIRECTOR

St. Petersburg Research Institute of Vaccines and Sera

Locations

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

Engel's, , Russia

Site Status: RECRUITING

Llc "Olla-Med"

Moscow, , Russia

Site Status: RECRUITING

LLC "Professorskaya Clinica"

Perm, , Russia

Site Status: NOT_YET_RECRUITING

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

Perm, , Russia

Site Status: ACTIVE_NOT_RECRUITING

LLC PiterClinica

Saint Petersburg, , Russia

Site Status: RECRUITING

LLC "DNA Research Center"

Saratov, , Russia

Site Status: RECRUITING

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

Yekaterinburg, , Russia

Site Status: ACTIVE_NOT_RECRUITING

Countries

Russia

Central Contacts

Ellina Ruzanova, PhD

Role: CONTACT

e.a.ruzanova@niivs.ru

(812) 660-06-39

Alla Emelyanova, PhD

Role: CONTACT

a.b.emelyanova@niivs.ru

(812) 660-06-39

Facility Contacts

Oksana Nesterenko, PhD

Role: primary

Maria Plekhanova, MD

Role: primary

Svetlana Teplykh, PhD

Role: primary

Tatiana Pak, PhD

Role: primary

Inna Gamova, PhD

Role: primary

Other Identifiers

FLМ-ТЕ-05-2021

Identifier Type: -

Identifier Source: org_study_id