Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra

NCT ID: NCT05308212

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 633 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2021-09-06

Brief Summary

Comparative assessment of the tolerability, safety, and immunogenicity of the FLU-M® Tetra quadrivalent inactivated split influenza vaccine and the Ultrix® vaccine in volunteers aged 60 years and above.

Detailed Description

Evaluation of the tolerability, safety and immunogenicity of the inactivated split influenza vaccine FLU-M® Tetra compared to Ultrix® vaccine in volunteers aged 60 years and above.

Volunteers were screened and randomized in three groups: the Flu-M Tetra w/p (with preservative) group, the Flu-M Tetra w/o/p (without preservative) group and the Ultrix® group. All subjects were followed up for 28 days post randomization and vaccination.

Conditions

Influenza

Study Design

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

Study Groups

FLU-M Tetra w/p

211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (with preservative) intramuscularly

Group Type: EXPERIMENTAL

Flu-M Tetra [Inactivated split influenza vaccine] w/p

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

FLU-M Tetra w/o/p

211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (without preservative) intramuscularly.

Group Type: EXPERIMENTAL

Flu-M Tetra [Inactivated split influenza vaccine] w/o/p

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Ultrix

211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Ultrix vaccine.

Group Type: ACTIVE_COMPARATOR

Ultrix [Inactivated split influenza vaccine]

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Interventions

Flu-M Tetra [Inactivated split influenza vaccine] w/p

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Flu-M Tetra [Inactivated split influenza vaccine] w/o/p

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Ultrix [Inactivated split influenza vaccine]

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Volunteers (men and women) at the age of 60 years and above

2. Written informed consent of volunteers to participate in the clinical trial;

3. Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's diary, come to follow-up visits);

4. For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination;

5. For fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years.

Exclusion Criteria

1. History of influenza/ARVI or previous influenza vaccination during 6 months before the trial;

2. Positive result of the SARS-CoV-2 test;

3. A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) 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);

4. Allergic reactions to vaccine components or any previous vaccination;

5. History of allergic reaction to chicken protein;

6. History of Guillain-Barré syndrome (acute polyneuropathy);

7. Previous vaccination with rabies vaccines less than 2 months before immunization or scheduled vaccination with rabies vaccines within 1 month after immunization with the trial vaccines;

8. History of leukemia, cancer, autoimmune diseases;

9. Positive blood test results for HIV, syphilis, hepatitis B/C.

10. Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;

11. History of long-term use (more than 14 days) of immunosuppressants or immunomodulatory drugs for six months before the trial;

12. History of any confirmed or suspected immunosuppressive or immunodeficiency condition;

13. History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, the gastrointestinal tract, liver, kidneys, hematopoietic, immune and endocrine system, mental disease in the acute stage or in the decompensation stage (recovery less than 4 weeks before vaccination);

14. History of eczema;

15. Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (> 10 mg of prednisolone or its equivalent for more than 14 days before the screening);

16. Tuberculosis, neurological or mental disorders, a convulsive syndrome, including in the past medical history;

17. History of acute infectious diseases (recovery less than 4 weeks before vaccination);

18. Consumption of more than 10 units of alcohol per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products;

19. Smoking of more than 10 cigarettes per day;

20. Participation in another clinical trial during the last 3 months;

21. Pregnancy or lactation;

22. Coagulopathy, haemophilia;

23. Taking aspirin or other antiplatelet agents in high doses.

• Minimum Eligible Age: 60 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

Locations

State Autonomous Health Institution "Engels City Clinical Hospital No1"

Engel's, , Russia

Limited Liability Company Professorskaya Clinica

Perm, , Russia

Limited Liability Company Energia Zdorovya

Saint Petersburg, , Russia

Limited Liability Company MEDICINSKAYA CLINIKA

Saint Petersburg, , Russia

Limited Liability Company Scientific Research Center Eco-Bezopasnost

Saint Petersburg, , Russia

Piramida Limited Liability Company

Saint Petersburg, , Russia

Private Health Care Institution Clinical Hospital "RZD-Medicine" in Saint Petersburg

Saint Petersburg, , Russia

Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 117"

Saint Petersburg, , Russia

Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 43"

Saint Petersburg, , Russia

Limited Liability Company "DNA Research Center"

Saratov, , Russia

Federal State Budget Healthcare Institution "Yaroslavl Region Clinical Hospital No. 2"

Yaroslavl, , Russia

Countries

Russia

Other Identifiers

FLM-TE-04-2020

Identifier Type: -

Identifier Source: org_study_id