Clinical trial NCT05126979: The Objectives of This Study Are Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
Official title: Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: influenza
flu
vaccine
Flu-M
Lead sponsor: St. Petersburg Research Institute of Vaccines and Sera
Sponsor class: OTHER_GOV
First posted: 2021-11-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years

Detailed description: All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.

Eligibility criteria: Inclusion Criteria:

* Written informed consent of the volunteers to participate in the clinical study;
* Healthy volunteers (men and women) aged 18-60 years;
* Volunteers with a titer of antibodies to A(H1N1), A(H3N2) and B influenza viruses less than 1:40 in a HI test
* Volunteers able to fulfill requirements of the protocol (i.e. fill out the patient's diary, come to follow-up visits);
* Female participants were obliged to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception for women of reproductive age)

Exclusion Criteria:

* Allergic reactions to chicken protein or any previous influenza vaccination;
* Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history;
* Volunteers who received immunoglobulin or blood products within the last three months before the study;
* Guillain-Barre syndrome (acute polyneuropathy) in the medical history;
* Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the study;
* Any confirmed or suspected immunosuppressive or immunodeficiency condition;
* Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests at Visit 1;
* Severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination;
* Volunteers who are (or were) patients of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary
* acute infectious and/or non-infectious diseases at the time of inclusion in the study;
* Exacerbation of chronic diseases;
* Alcohol abuse and/or use of drugs in the past history;
* Pregnancy and lactation;
* Participation in another clinical study within the last 3 months

Primary outcomes:
measure: Severity of reported local reactions and their relationship with the vaccination
timeFrame: days 1-7
measure: Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days)
timeFrame: days 1-7
measure: Severity of local reactions reported by participants of the study and their relationship with the vaccination
timeFrame: days 8-20
measure: Severity of system reactions reported by participants of the study and their relationship with the vaccination
timeFrame: days 8-20
measure: The measurement physical data at each visit of the trial site by the volunteer
timeFrame: days 1-20
Secondary outcomes:
measure: The immunogenicity assessment of the vaccine was carried out by the seroconversion factor
timeFrame: Measurements will be taken at screening, then up to 21 days post-vaccination
measure: The immunogenicity assessment of the vaccine was carried out by Geometric mean titer
timeFrame: Measurements will be taken at screening, then up to 21 days post-vaccination
measure: The immunogenicity assessment of the vaccine was carried out by seroprotection levels
timeFrame: Measurements will be taken at screening, then up to 21 days post-vaccination
measure: The immunogenicity assessment of the vaccine was carried out by seroconversion
timeFrame: Measurements will be taken at screening, then up to 21 days post-vaccination
Other outcomes:
Locations:
city: Perm
country: Russian Federation
facility: Perm State Medical University named after academician E.A. Wagner
Study officials:
References: