Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Flu-M [Inactivated split influenza vaccine]
Inactivated influenza split vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, flu, vaccine, Flu-M
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Infection Center
- Perm State Medical University named after Academician E. A. Wagner
- Research Institute of Influenza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flu-M
Vaxigrip
Arm Description
200 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative
200 volunteers were vaccinated with the Vaxigrip® inactivated split influenza vaccine
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
Results of assessment of heart rate (HR)
The measurement of HR at each visit of the trial site by the volunteer
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
Results of biochemical blood tests
ALT (U/L)
AST (U/L)
Alkaline phosphatase (U/L)
Results of biochemical blood tests
Bilirubin total (µmol/l)
Results of biochemical blood tests
Total protein (g/l)
Results of biochemical blood tests
C-reactive protein (mg/l)
Results of biochemical blood tests
Urea (mmol/l)
Glucose (mmol/l)
Creatinine (mmol/l)
Results of complete blood counts
Erythrocytes (10^12/L)
Results of complete blood counts
Hemoglobin (g/L)
Results of complete blood counts
Erythrocyte sedimentation reaction (ESR) (mm/h)
Results of complete blood counts
Leukocytes, (х 10^9/L)
Leukocytic formula:
Stab neutrophils, % Segmented neutrophils (%) Eosinophils, (%) Basophils, (%) Lymphocytes, (%) Monocytes, (%)
Results of complete blood counts
Platelets, (х 10^9/L)
Incidence of AEs associated with the vaccination
Incidence of SAEs associated with the vaccination
Secondary Outcome Measures
Full Information
NCT ID
NCT05297994
First Posted
October 11, 2021
Last Updated
March 16, 2022
Sponsor
St. Petersburg Research Institute of Vaccines and Sera
1. Study Identification
Unique Protocol Identification Number
NCT05297994
Brief Title
Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA
Official Title
Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA vs. the Vaxigrip® Inactivated Influenza Split Vaccine Manufactured by Sanofi Pasteur, France, in Volunteers Aged 18-60 Years
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 24, 2016 (Actual)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
March 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg Research Institute of Vaccines and Sera
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, flu, vaccine, Flu-M
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flu-M
Arm Type
Experimental
Arm Description
200 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative
Arm Title
Vaxigrip
Arm Type
Active Comparator
Arm Description
200 volunteers were vaccinated with the Vaxigrip® inactivated split influenza vaccine
Intervention Type
Biological
Intervention Name(s)
Flu-M [Inactivated split influenza vaccine]
Intervention Description
solution for intramuscular injection, 0.5 ml
Intervention Type
Biological
Intervention Name(s)
Inactivated influenza split vaccine
Intervention Description
solution for intramuscular injection, 0.5 ml
Primary Outcome Measure Information:
Title
Severity of observed local reactions and their relationship with the vaccination
Description
% 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
Title
Severity of observed local reactions and their relationship with the vaccination
Description
% 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
Title
Severity of observed local reactions and their relationship with the vaccination
Description
% 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
Title
Severity of observed local reactions and their relationship with the vaccination
Description
% 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
Title
Severity of observed system reactions and their relationship with the vaccination
Description
% 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
Title
Severity of observed system reactions and their relationship with the vaccination
Description
% 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
Time Frame
days 1-21 post-vaccination
Title
Severity of observed system reactions and their relationship with the vaccination
Description
% 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
Title
Results of assessment of heart rate (HR)
Description
The measurement of HR at each visit of the trial site by the volunteer
Time Frame
days 1-21 post-vaccination
Title
Results of assessment of systolic and diastolic blood pressure (BP)
Description
The measurement of systolic and diastolic BP at each visit of the trial site by the volunteer
Time Frame
days 1-21 post-vaccination
Title
Results of biochemical blood tests
Description
ALT (U/L)
AST (U/L)
Alkaline phosphatase (U/L)
Time Frame
days 3, 7 and 21
Title
Results of biochemical blood tests
Description
Bilirubin total (µmol/l)
Time Frame
days 3, 7 and 21
Title
Results of biochemical blood tests
Description
Total protein (g/l)
Time Frame
days 3, 7 and 21
Title
Results of biochemical blood tests
Description
C-reactive protein (mg/l)
Time Frame
days 3, 7 and 21
Title
Results of biochemical blood tests
Description
Urea (mmol/l)
Glucose (mmol/l)
Creatinine (mmol/l)
Time Frame
days 3, 7 and 21
Title
Results of complete blood counts
Description
Erythrocytes (10^12/L)
Time Frame
days 3, 7 and 21
Title
Results of complete blood counts
Description
Hemoglobin (g/L)
Time Frame
days 3, 7 and 21
Title
Results of complete blood counts
Description
Erythrocyte sedimentation reaction (ESR) (mm/h)
Time Frame
days 3, 7 and 21
Title
Results of complete blood counts
Description
Leukocytes, (х 10^9/L)
Leukocytic formula:
Stab neutrophils, % Segmented neutrophils (%) Eosinophils, (%) Basophils, (%) Lymphocytes, (%) Monocytes, (%)
Time Frame
days 3, 7 and 21
Title
Results of complete blood counts
Description
Platelets, (х 10^9/L)
Time Frame
days 3, 7 and 21
Title
Incidence of AEs associated with the vaccination
Time Frame
days 1-21 post-vaccination
Title
Incidence of SAEs associated with the vaccination
Time Frame
days 1-21 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Infection Center
City
Novosibirsk
Country
Russian Federation
Facility Name
Perm State Medical University named after Academician E. A. Wagner
City
Perm
Country
Russian Federation
Facility Name
Research Institute of Influenza
City
Saint Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA
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