The Objectives of This Study Are Study the Safety, Reactogenicity and Obtain Preliminary Data on the Immunogenicity of Flu-M Quadro, 4-valent Inactivated Split Influenza Vaccine, in Healthy Volunteers

Phase I Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, Produced by FSUE SPbSRIVS FMBA, vs. Placebo in Healthy Volunteers

The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Flu-M Quadro [inactivated split influenza vaccine] with preservative; Biological: Flu-M Quadro [inactivated split influenza vaccine] without preservative; Biological: Placebo

Detailed Description

The maximum period of the volunteers' participation in the trial will be 35 ± 2 days. Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period - 28±2 days.

All volunteers are followed by a clinical investigator for 6 months after vaccination outside of this trial with the aim of detecting possible late adverse reactions. If a volunteer has any delayed-type reactions, the volunteer will be invited to the clinic for correction of his/her condition.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation
    • Federally Funded Healthcare Institution Primary Healthcare Unit No. 163

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:

• Voluntarily and personally signed form of informed consent for participation in the trial, before any trial procedure is carried out.
• Verified diagnosis "healthy", at that the clinical investigator shall confirm the absence of pathology on the part of the main organs and systems, previously conducted standard clinical, laboratory and instrumental studies did not reveal any diseases.
• Age between 18 and 60 years old, inclusively.
• Ability to attend all planned visits and all scheduled procedures and studies.
• Willingness of the volunteers to complete Self-Observation Diaries in between their visits to a clinical center.
• Previous vaccination against seasonal influenza at least 9 months prior to inclusion in this trial.
• Consent of the volunteers to use effective contraception methods contraception throughout the trial, including the term of observation for possible post-vaccination reactions

Exclusion Criteria:

• Known hypersensitivity to any of the components of the tested products, as well as to chicken meat or chicken/quail eggs.
• Allergic reaction to any previous influenza vaccination.
• Adverse reaction of severe degree of manifestation or serious adverse reaction to previous influenza vaccine administration.
• Signs of any disease at the time of inclusion in the trial or if less than 4 weeks have expired after recovery.
• Any acute respiratory disease less than 3 months before inclusion in the trial.
• Guillain-Barré syndrome (acute polyneuropathy) in the medical history.
• History of leukemia, tuberculosis, cancer, autoimmune diseases.
• Volunteers who received immunoglobulin or blood products within the last three months before the trial.
• Long-term use (exceeding 14 days) of immunosuppressants, systemic corticosteroids or immunomodulatory agents within 6 months before the trial
• Vaccination with any vaccine within one month before the vaccination.
• Acute infectious or non-communicable diseases, acute exacerbation of a chronic diseases within 4 weeks before the screening.
• Scheduled use of vaccines not provided by the tested protocol within 30 days (inclusively) after the vaccination.
• Pregnant and breastfeeding women.
• Positive blood test results for HIV, syphilis, hepatitis B/C.
• Participation in another clinical trial within 30 days before the screening visit or in parallel with the current trial.
• History of alcohol addiction, drug addiction or abuse of pharmaceutical products.
• Inability or inability to meet the requirements of the protocol, inter lia, for physical, mental or social reasons, according to the clinical investigator

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 Quadro with preservative; 25 volunteers were vaccinated with the Flu-M Quadro inactivated split influenza vaccine with a preservative	Biological: Flu-M Quadro [inactivated split influenza vaccine] with preservative; solution for intramuscular injection, 0.5 ml
Experimental: Flu-M Quadro without preservative; 25 volunteers were vaccinated with the Flu-M Quadro inactivated split influenza vaccine without a preservative	Biological: Flu-M Quadro [inactivated split influenza vaccine] without preservative; solution for intramuscular injection, 0.5 ml
Placebo Comparator: Placebo; 25 volunteers were vaccinated with a Placebo	Biological: Placebo; solution for intramuscular injection, 0.5 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (local and systemic post-vaccination reactions)	days 1-7
Incidence of adverse events (systemic post-vaccination reactions)	days 1-7
Incidence of any serious adverse events during the trial	days 1-28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The content of specific anti-influenza antibodies in serum		days 0, 28 after the vaccination
The geometric mean titer (GMT) of antibodies to hemagglutinins of the influenza virus		days 0, 28 after the vaccination
Seroconversion factor	It shout be more than 2.5 after the vaccination	days 0, 28
Seroconversion level		days 0, 28 after the vaccination
Seroprotection level		days 0, 28 after the vaccination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2019
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: vaccine; influenza; flu; Flu-M; FluM Tetra; Tetra; SPbSRIVS; Quadro
• 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: FMVq-I-001/18

Drug and device information, study documents

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