Clinical trial NCT05308212: Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra
Official title: Multicenter, Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra Inactivated Vaccine in Volunteers Aged 60 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Influenza
Keywords: influenza
flu
vaccine
FLU-M Tetra
Lead sponsor: St. Petersburg Research Institute of Vaccines and Sera
Sponsor class: OTHER_GOV
First posted: 2022-04-04
Enrollment: 633
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Geometric mean titer (GMT) ratio of antibodies after vaccination
timeFrame: days 0, 28
Secondary outcomes:
measure: Change from baseline seroconversion rate at 28 days
timeFrame: days 0, 28
measure: Seroconversion factor
timeFrame: days 0, 28
measure: Seroprotection rate
timeFrame: days 0, 28
measure: Frequency of development of AEs associated with the vaccination
timeFrame: days 0-28
measure: Frequency of development of SAEs associated with the vaccination
timeFrame: days 0-28
measure: Number of participants with abnormal physical examination findings
timeFrame: days 0,1,3,7,28
measure: Results of assessment of blood pressure (BP)
timeFrame: days 0,1,3,7,28
measure: Results of assessment of heart rate (HR)
timeFrame: days 0,1,3,7,28
measure: Results of E immunoglobulin tests
timeFrame: days 0,3,28
measure: Results of assessment of respiratory rate (RR)
timeFrame: days 0,1,3,7,28
measure: Results of assessment of body temperature
timeFrame: days 0,1,3,7,28
measure: Number of participants with abnormal neurological examinations
timeFrame: days 0,1,3,7,28
measure: Number of participants with abnormal ECG findings
timeFrame: days 0,3
measure: Number of participants with abnormal complete blood counts results
timeFrame: days 0,3
measure: Number of participants with abnormal biochemical blood tests results
timeFrame: days 0,3
measure: Number of participants with abnormal urinalysis results
timeFrame: days 0,3
Other outcomes:
Locations:
city: Engels
country: Russian Federation
facility: State Autonomous Health Institution "Engels City Clinical Hospital No1"
city: Perm
country: Russian Federation
facility: Limited Liability Company Professorskaya Clinica
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company Energia Zdorovya
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company MEDICINSKAYA CLINIKA
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company Scientific Research Center Eco-Bezopasnost
city: Saint Petersburg
country: Russian Federation
facility: Piramida Limited Liability Company
city: Saint Petersburg
country: Russian Federation
facility: Private Health Care Institution Clinical Hospital "RZD-Medicine" in Saint Petersburg
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 117"
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 43"
city: Saratov
country: Russian Federation
facility: Limited Liability Company "DNA Research Center"
city: Yaroslavl
country: Russian Federation
facility: Federal State Budget Healthcare Institution "Yaroslavl Region Clinical Hospital No. 2"
Study officials:
References: