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Completed

NCT Number: NCT05297994

Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA

To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split influenza vaccine in volunteers aged 18-60 years

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Infection Center, Novosibirsk, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flu-M [Inactivated split influenza vaccine]

Biological

solution for intramuscular injection, 0.5 ml

Inactivated influenza split vaccine

Biological

solution for intramuscular injection, 0.5 ml

Primary outcomes

  1. Severity of observed local reactions and their relationship with the vaccination

    Time frame: days 1-21 post-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

  2. Severity of observed local reactions and their relationship with the vaccination

    Time frame: days 1-21 post-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

  3. Severity of observed local reactions and their relationship with the vaccination

    Time frame: days 1-21 post-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

  4. Severity of observed local reactions and their relationship with the vaccination

    Time frame: 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 severity

  5. Severity of observed system reactions and their relationship with the vaccination

    Time frame: days 1-21 post-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

  6. Severity of observed system reactions and their relationship with the vaccination

    Time frame: days 1-21 post-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

  7. Severity of observed system reactions and their relationship with the vaccination

    Time frame: 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 severity

  8. Results of assessment of heart rate (HR)

    Time frame: days 1-21 post-vaccination

    The measurement of HR at each visit of the trial site by the volunteer

  9. Results of assessment of systolic and diastolic blood pressure (BP)

    Time frame: days 1-21 post-vaccination

    The measurement of systolic and diastolic BP at each visit of the trial site by the volunteer

  10. Results of biochemical blood tests

    Time frame: days 3, 7 and 21

    • ALT (U/L)
    • AST (U/L)
    • Alkaline phosphatase (U/L)

  11. Results of biochemical blood tests

    Time frame: days 3, 7 and 21

    Bilirubin total (µmol/l)

  12. Results of biochemical blood tests

    Time frame: days 3, 7 and 21

    Total protein (g/l)

  13. Results of biochemical blood tests

    Time frame: days 3, 7 and 21

    C-reactive protein (mg/l)

  14. Results of biochemical blood tests

    Time frame: days 3, 7 and 21

    • Urea (mmol/l)
    • Glucose (mmol/l)
    • Creatinine (mmol/l)

  15. Results of complete blood counts

    Time frame: days 3, 7 and 21

    Erythrocytes (10^12/L)

  16. Results of complete blood counts

    Time frame: days 3, 7 and 21

    Hemoglobin (g/L)

  17. Results of complete blood counts

    Time frame: days 3, 7 and 21

    Erythrocyte sedimentation reaction (ESR) (mm/h)

  18. Results of complete blood counts

    Time frame: days 3, 7 and 21

    Leukocytes, (х 10^9/L)

    Leukocytic formula:

    Stab neutrophils, % Segmented neutrophils (%) Eosinophils, (%) Basophils, (%) Lymphocytes, (%) Monocytes, (%)

  19. Results of complete blood counts

    Time frame: days 3, 7 and 21

    Platelets, (х 10^9/L)

  20. Incidence of AEs associated with the vaccination

    Time frame: days 1-21 post-vaccination

  21. Incidence of SAEs associated with the vaccination

    Time frame: days 1-21 post-vaccination

Sponsors and collaborators

Lead sponsor

St. Petersburg Research Institute of Vaccines and Sera

Other Gov

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 28, 2022
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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