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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Flu-M [Inactivated split influenza vaccine]; Biological: Inactivated influenza split vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation
    • Infection Center
  • Perm, Russian Federation
    • Perm State Medical University named after Academician E. A. Wagner
  • Saint Petersburg, Russian Federation
    • Research Institute of Influenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flu-M; 200 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative	Biological: Flu-M [Inactivated split influenza vaccine]; solution for intramuscular injection, 0.5 ml
Active Comparator: Vaxigrip; 200 volunteers were vaccinated with the Vaxigrip® inactivated split influenza vaccine	Biological: Inactivated influenza split vaccine; solution for intramuscular injection, 0.5 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	% 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2016
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): March 9, 2017

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: vaccine; influenza; flu; Flu-M
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FMV-VGIR-II-001/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No