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

NCT05297994 | Completed Phase 2

• 1 other identifier: FMV-VGIR-II-001/16
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Influenza

Keywords

influenza; flu; vaccine; Flu-M

Outcome Measures

Primary Outcomes (21)

• 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

  % 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

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

  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

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

  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

Study Arms (2)

Flu-M

EXPERIMENTAL

200 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative

Biological: Flu-M [Inactivated split influenza vaccine]

Vaxigrip

ACTIVE COMPARATOR

200 volunteers were vaccinated with the Vaxigrip® inactivated split influenza vaccine

Biological: Inactivated influenza split vaccine

Interventions

Flu-M [Inactivated split influenza vaccine] BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Flu-M

Inactivated influenza split vaccine BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Vaxigrip

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• St. Petersburg Research Institute of Vaccines and Sera: lead

Study Sites (3)

Infection Center

Novosibirsk, Russia

Location

Perm State Medical University named after Academician E. A. Wagner

Perm, Russia

Location

Research Institute of Influenza

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: March 28, 2022
• Study Start: October 24, 2016
• Primary Completion: December 12, 2016
• Study Completion: March 9, 2017
• Last Updated: March 28, 2022

Record last verified: 2021-10

Locations

RU (3)