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

NCT05152017 | Completed Phase 1

• 1 other identifier: FMVq-I-001/18
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Keywords

influenza; flu; vaccine; Flu-M; FluM Tetra; Tetra; SPbSRIVS; Quadro

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

  days 0, 28

• Seroconversion level

  days 0, 28 after the vaccination

• Seroprotection level

  days 0, 28 after the vaccination

Study Arms (3)

Flu-M Quadro with preservative

EXPERIMENTAL

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

Flu-M Quadro without preservative

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

25 volunteers were vaccinated with a Placebo

Biological: Placebo

Interventions

Flu-M Quadro [inactivated split influenza vaccine] with preservative BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Flu-M Quadro with preservative

Flu-M Quadro [inactivated split influenza vaccine] without preservative BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Flu-M Quadro without preservative

Placebo BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Consent of the volunteers to use effective contraception methods contraception throughout the trial, including the term of observation for possible post-vaccination reactions

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

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

Study Sites (1)

Federally Funded Healthcare Institution Primary Healthcare Unit No. 163

Novosibirsk, 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: November 26, 2021
• First Posted: December 9, 2021
• Study Start: November 16, 2019
• Primary Completion: January 22, 2020
• Study Completion: January 24, 2020
• Last Updated: January 6, 2022

Record last verified: 2021-11

Locations

RU (1)