To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split influenza vaccine in volunteers aged 18-60 years
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
400
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
Infection Center
Novosibirsk, Russia
Perm State Medical University named after Academician E. A. Wagner
Perm, Russia
Research Institute of Influenza
Saint Petersburg, Russia
Severity of observed local reactions and their relationship with the vaccination
% of patients with: • Pain at the injection site at pressing Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity
Time frame: days 1-21 post-vaccination
Severity of observed local reactions and their relationship with the vaccination
% of patients with: • Hyperemia; Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity
Time frame: days 1-21 post-vaccination
Severity of observed local reactions and their relationship with the vaccination
% of patients with: • Infiltrate Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity
Time frame: days 1-21 post-vaccination
Severity of observed local reactions and their relationship with the 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 severity
Time frame: days 1-21 post-vaccination
Severity of observed system reactions and their relationship with the vaccination
% of patients with: • Fever Measurement tool: 4-point scale: 0 - none (≤ 37°С), 1 - mild (\> 37°С - ≤ 37.5°С), 2 - moderate (\> 37.6°С - ≤ 38.5°С), 3 - severe (\> 38.6°С). Unit of measure: % of symptomatic patients at each severity
Time frame: days 1-21 post-vaccination
Severity of observed system reactions and their relationship with the vaccination
% of patients with: • Chills Measurement tool: 4-point scale: 0 - none, 1 - mild, 2 - moderate, 3 - severe. Unit of measure: % of symptomatic patients at each severity
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Time frame: days 1-21 post-vaccination
Severity of observed system reactions and their relationship with the 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 severity
Time frame: days 1-21 post-vaccination
Results of assessment of heart rate (HR)
The measurement of HR at each visit of the trial site by the volunteer
Time frame: days 1-21 post-vaccination
Results of assessment of systolic and diastolic blood pressure (BP)
The measurement of systolic and diastolic BP at each visit of the trial site by the volunteer
Time frame: days 1-21 post-vaccination
Results of biochemical blood tests
* ALT (U/L) * AST (U/L) * Alkaline phosphatase (U/L)
Time frame: days 3, 7 and 21
Results of biochemical blood tests
Bilirubin total (µmol/l)
Time frame: days 3, 7 and 21
Results of biochemical blood tests
Total protein (g/l)
Time frame: days 3, 7 and 21
Results of biochemical blood tests
C-reactive protein (mg/l)
Time frame: days 3, 7 and 21
Results of biochemical blood tests
* Urea (mmol/l) * Glucose (mmol/l) * Creatinine (mmol/l)
Time frame: days 3, 7 and 21
Results of complete blood counts
Erythrocytes (10\^12/L)
Time frame: days 3, 7 and 21
Results of complete blood counts
Hemoglobin (g/L)
Time frame: days 3, 7 and 21
Results of complete blood counts
Erythrocyte sedimentation reaction (ESR) (mm/h)
Time frame: days 3, 7 and 21
Results of complete blood counts
Leukocytes, (х 10\^9/L) Leukocytic formula: Stab neutrophils, % Segmented neutrophils (%) Eosinophils, (%) Basophils, (%) Lymphocytes, (%) Monocytes, (%)
Time frame: days 3, 7 and 21
Results of complete blood counts
Platelets, (х 10\^9/L)
Time frame: days 3, 7 and 21
Incidence of AEs associated with the vaccination
Time frame: days 1-21 post-vaccination
Incidence of SAEs associated with the vaccination
Time frame: days 1-21 post-vaccination