The Objectives of This Study Are Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years

Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years

Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Placebo; Biological: Inactivated Split Influenza 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): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Perm, Russian Federation
    • Perm State Medical University named after Academician E.A. Wagner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent of the volunteers to participate in the clinical study;
• Healthy volunteers (men and women) aged 18-60 years;
• Volunteers with a titer of antibodies to A(H1N1), A(H3N2) and B influenza viruses less than 1:40 in a HI test
• Volunteers able to fulfill requirements of the protocol (i.e. fill out the patient's diary, come to follow-up visits);
• Female participants were obliged to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception for women of reproductive age)

Exclusion Criteria:

• Allergic reactions to chicken protein or any previous influenza vaccination;
• Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history;
• Volunteers who received immunoglobulin or blood products within the last three months before the study;
• Guillain-Barre syndrome (acute polyneuropathy) in the medical history;
• Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the study;
• Any confirmed or suspected immunosuppressive or immunodeficiency condition;
• Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests at 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;
• Volunteers who are (or were) patients 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 study;
• Exacerbation of chronic diseases;
• Alcohol abuse and/or use of drugs in the past history;
• Pregnancy and lactation;
• Participation in another clinical study within the last 3 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flu-M (without a preservative); 15 volunteers were treated with the Flu-M inactivated split influenza vaccine without a preservative	Biological: Inactivated Split Influenza Vaccine
Experimental: Flu-M (with a preservative); 15 volunteers were treated with the Flu-M inactivated split influenza vaccine with a preservative	Biological: Inactivated Split Influenza Vaccine
Placebo Comparator: Placebo; 15 volunteers were treated with a placebo	Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Severity of reported local reactions and their relationship with the vaccination	days 1-7
Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days)	days 1-7
Severity of local reactions reported by participants of the study and their relationship with the vaccination	days 8-20
Severity of system reactions reported by participants of the study and their relationship with the vaccination	days 8-20
The measurement physical data at each visit of the trial site by the volunteer	days 1-20

Secondary Outcome Measures

Outcome Measure	Time Frame
The immunogenicity assessment of the vaccine was carried out by the seroconversion factor	Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by Geometric mean titer	Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by seroprotection levels	Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by seroconversion	Measurements will be taken at screening, then up to 21 days post-vaccination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2016
• Primary Completion (Actual): April 25, 2016
• Study Completion (Actual): May 13, 2016

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• 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
• Other Study ID Numbers: FMV-VGIR-1-001/15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No