Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine

NCT05869201 | Completed Phase 2

• 1 other identifier: FMK-II/III-02/20
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this clinical trial is to assess tolerability, safety and immunogenicity of the Flu-M Quadro vaccine as compared to the Ultrix® Quadri vaccine in volunteers aged between 18 and 60. Participants were given Flu-M Quadro \[inactivated split influenza vaccine\] with preservative or Flu-M Quadro \[inactivated split influenza vaccine\] without preservative or Ultrix® Quadri vaccine.The volunteers of each group were vaccinated with a single dose vaccine. Researchers assessed the tolerability, safety and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine. Researchers performed a comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine and the Ultrix® Quadri vaccine.

Conditions

Influenza; Influenza, Human; Influenza Viral Infections; Vaccine Reaction; Vaccination; Infection

Keywords

Influenza; Flu; Vaccine; Vaccination; SPbSRIVS; Flu-M Tetra; Flu-M Quadro; Quadrivalent; Inactivated; Split

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) The percentage of subjects who have a prevaccination titer of influenza haemagglutinin antibody titer (HA titer) ≤ 1:10 and a postvaccination HA titer

  Screening (Days 0+5), Day 28

Secondary Outcomes (21)

• Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line))

  Screening (Days 0+5), Day 28

• Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) Seroconversion factor is an increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise

  Screening (Days 0+5), Day 28

• Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) Seroprotection rate is the percentage of subjects with a generated protective HA titer (at least 1:40) vs. the baseline level

  Screening (Days 0+5), Day 28

• Incidence of influenza and ARVI

  During 6 months after vaccination

• Incidence of immediate adverse events (allergic reactions)

  2 hours after vaccination

Study Arms (3)

Flu-M Quadro with preservative

EXPERIMENTAL

150 volunteers were vaccinated with the Flu-M Quadro Inactivated Split Influenza Vaccine with a preservative

Biological: Influenza vaccine [inactivated]

Flu-M Quadro without preservative

EXPERIMENTAL

150 volunteers were vaccinated with the Flu-M Quadro Inactivated Split Influenza Vaccine without a preservative

Biological: Influenza vaccine [inactivated]

Ultrix® Quadri

ACTIVE COMPARATOR

150 volunteers were vaccinated with Ultrix® Quadri Vaccine

Biological: Influenza vaccine [inactivated]

Interventions

Influenza vaccine [inactivated] BIOLOGICAL

Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine

Also known as: Flu-M Quadro (with a preservative)

Flu-M Quadro with preservative

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers (men and women) aged 18-60;
• Written informed consent of the volunteers to participate in the clinical trial;
• Volunteers able to fulfill requirements of the protocol (i.e., fill out the patient's diary, come to follow-up visits);
• For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception (usage of contraceptives one month before vaccination and at least two months after vaccination). All females with childbearing potential must have a negative pregnancy test result during the screening period. In the course of the trial women should use barrier contraceptives with a reliability exceeding 90 %, or be sterile, or be in a postmenopausal state. Barrier contraceptives with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals;
• For the men, are able to conceive - consent to use adequate contraception methods. In the course of the trial and during at least two months after vaccination, men and their sexual partners should use barrier contraceptives with a reliability exceeding 90 %, or be sterile. Barrier contraceptives with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals;

You may not qualify if:

• History of influenza or ARVI or previous influenza vaccination during 9 moths before the trial;
• A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
• Allergic reactions to vaccine components or any previous vaccination;
• History of allergic reaction to chicken protein;
• History of Guillain-Barré syndrome (acute polyneuropathy);
• Previous vaccination with rabies vaccines less than 2 months before immunization or scheduled vaccination with rabies vaccines within 1 month after immunization with the trial vaccines;
• Use of any vaccines within 1 month before the vaccination, excluding vaccines according to the National Calendar of Preventive Vaccination, including for epidemic reasons;
• History of leukemia, tuberculosis, cancer, autoimmune diseases;
• Positive blood test results for HIV, syphilis, hepatitis B/C.
• Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;
• History of long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the trial;
• History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
• History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, the gastrointestinal tract, liver, kidneys, hematopoietic or immune systems, mental disease in the acute stage or in the decompensation stage (recovery less than 4 weeks before vaccination);
• History of progressive neurological pathology, convulsive syndrome; Diabetes mellitus, thyrotoxicosis or other diseases of the endocrine system;
• History of eczema;

Sponsors & Collaborators

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

Study Sites (5)

Federally Funded Healthcare Institution Primary Healthcare Unit No. 163,of Federal Medical and Biologic Agency (FFHI PHU No. 163, FMBA of Russia)

Kol'tsovo, Novosibirsk Oblast, Russia

Location

Bessalar Clinic. Clinical Trial Center Limited Liability Company (Bessalar Clinic. Clinical Trial Center LLC)

Moscow, Russia

Location

Federation (FSBEI of Higher Education "E. A. Wagner PSMU" of the of the Ministry of Health of the Russian Federation)

Perm, Russia

Location

Baltic Medicine Limited Liability Company (Baltic Medicine LLC)

Saint Petersburg, Russia

Location

Eco-Safety Scientific Research and Development Center Limited Liability Company (Eco-Safety Scientific Research and Development Center LLC)

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Influenza, Human; Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ellina Ruzanova

  St. Petersburg Research Institute of Vaccines and Sera

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: October 6, 2020
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

RU (5)