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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flu-M | Experimental | 200 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative |
|
| Vaxigrip | Active Comparator | 200 volunteers were vaccinated with the Vaxigrip® inactivated split influenza vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flu-M [Inactivated split influenza vaccine] | Biological | solution for intramuscular injection, 0.5 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | days 1-21 post-vaccination |
| Severity of observed system reactions and their relationship with the vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infection Center | Novosibirsk | Russia | ||||
| Perm State Medical University named after Academician E. A. Wagner |
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| Inactivated influenza split vaccine | Biological | solution for intramuscular injection, 0.5 ml |
|
% 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 |
| 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 | 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 | 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 | days 1-21 post-vaccination |
| Results of biochemical blood tests |
| days 3, 7 and 21 |
| Results of biochemical blood tests | Bilirubin total (µmol/l) | days 3, 7 and 21 |
| Results of biochemical blood tests | Total protein (g/l) | days 3, 7 and 21 |
| Results of biochemical blood tests | C-reactive protein (mg/l) | days 3, 7 and 21 |
| Results of biochemical blood tests |
| days 3, 7 and 21 |
| Results of complete blood counts | Erythrocytes (10^12/L) | days 3, 7 and 21 |
| Results of complete blood counts | Hemoglobin (g/L) | days 3, 7 and 21 |
| Results of complete blood counts | Erythrocyte sedimentation reaction (ESR) (mm/h) | 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, (%) | days 3, 7 and 21 |
| Results of complete blood counts | Platelets, (х 10^9/L) | days 3, 7 and 21 |
| Incidence of AEs associated with the vaccination | days 1-21 post-vaccination |
| Incidence of SAEs associated with the vaccination | days 1-21 post-vaccination |
| Perm |
| Russia |
| Research Institute of Influenza | Saint Petersburg | Russia |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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