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

NCT05126979 | Completed Phase 1

• 1 other identifier: FMV-VGIR-1-001/15
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Keywords

influenza; flu; vaccine; Flu-M

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (3)

Flu-M (without a preservative)

EXPERIMENTAL

15 volunteers were treated with the Flu-M inactivated split influenza vaccine without a preservative

Biological: Inactivated Split Influenza Vaccine

Flu-M (with a preservative)

EXPERIMENTAL

15 volunteers were treated with the Flu-M inactivated split influenza vaccine with a preservative

Biological: Inactivated Split Influenza Vaccine

Placebo

PLACEBO COMPARATOR

15 volunteers were treated with a placebo

Biological: Placebo

Interventions

Inactivated Split Influenza Vaccine BIOLOGICAL

Flu-M (with a preservative); Flu-M (without a preservative)

Placebo BIOLOGICAL

Placebo

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 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Perm, 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 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: November 19, 2021
• Study Start: March 9, 2016
• Primary Completion: April 25, 2016
• Study Completion: May 13, 2016
• Last Updated: January 6, 2022

Record last verified: 2021-10

Locations

RU (1)