Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA
- Conditions
- Influenza
- Interventions
- Biological: Inactivated influenza split vaccineBiological: Flu-M [Inactivated split influenza vaccine]
- Registration Number
- NCT05297994
- Brief Summary
To trial the reactogenicity, safety and immunogenicity of the 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Written informed consent of the volunteers to participate in the clinical trial;
- Healthy volunteers (men and women) aged 18-60 years;
- Volunteers able to fulfill requirements of the protocol (fill out the patient's diary, come to follow-up visits);
- If the participant is female, she was required to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception of women of reproductive period)
- Allergic reactions to chicken protein or any previous influenza vaccination;
- Leukemia, cancer or a positive reaction to human immunodeficiency virus infection, hepatitis B and C, syphilis in the past medical history;
- Volunteers who received immunoglobulin or blood products within the last 3 months before the trial;
- Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
- Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for 6 months prior to the trial.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition;
- Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests during 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;
- Being (or having been) a patient 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 trial;
- Exacerbation of chronic diseases;
- chronic alcohol abuse and/or use of drugs in the past history;
- Pregnancy and lactation;
- Participation in another clinical trial within the last 3 months;
- Immunization with influenza vaccines in the last 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaxigrip Inactivated influenza split vaccine 200 volunteers were vaccinated with the Vaxigrip® inactivated split influenza vaccine Flu-M Flu-M [Inactivated split influenza vaccine] 200 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative
- Primary Outcome Measures
Name Time Method Results of complete blood counts days 3, 7 and 21 Platelets, (х 10\^9/L)
Severity of observed local reactions and their relationship with the vaccination days 1-21 post-vaccination % of patients with:
• Swelling Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severitySeverity of observed system reactions and their relationship with the vaccination days 1-21 post-vaccination % of patients with:
• Increased sweating Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severityResults of assessment of heart rate (HR) days 1-21 post-vaccination The measurement of HR at each visit of the trial site by the volunteer
Incidence of AEs associated with the vaccination days 1-21 post-vaccination Incidence of SAEs associated with the vaccination days 1-21 post-vaccination Results of assessment of systolic and diastolic blood pressure (BP) days 1-21 post-vaccination The measurement of systolic and diastolic BP at each visit of the trial site by the volunteer
Results of biochemical blood tests days 3, 7 and 21 * Urea (mmol/l)
* Glucose (mmol/l)
* Creatinine (mmol/l)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Infection Center
🇷🇺Novosibirsk, Russian Federation
Perm State Medical University named after Academician E. A. Wagner
🇷🇺Perm, Russian Federation
Research Institute of Influenza
🇷🇺Saint Petersburg, Russian Federation