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

NCT ID: NCT05869201

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2020-12-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Flu-M Quadro with preservative

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

Group Type: EXPERIMENTAL

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

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

Flu-M Quadro without preservative

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

Group Type: EXPERIMENTAL

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

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

Ultrix® Quadri

150 volunteers were vaccinated with Ultrix® Quadri Vaccine

Group Type: ACTIVE_COMPARATOR

Influenza vaccine [inactivated]

Intervention Type: BIOLOGICAL

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

Interventions

Influenza vaccine [inactivated]

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

Intervention Type: BIOLOGICAL

Influenza vaccine [inactivated]

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

Intervention Type: BIOLOGICAL

Influenza vaccine [inactivated]

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Flu-M Quadro (with a preservative); Flu-M Quadro (without preservative); Ultrix® Quadri

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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;
• Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (> 10 mg of prednisolone or its equivalent for more than 14 days during the last three months);
• According to the medical history, the volunteer was/is a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary and/or other;
• History of acute infectious diseases (recovery less than 4 weeks before vaccination);
• Consumption of more than 10 units of alcoholic drinks per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products;
• Smoking of more than 10 cigarettes per day;
• Participation in another clinical trial during the last 3 months;
• Pregnancy or lactation;
• Serious concurrent illnesses or pathological conditions not listed above which, in the opinion of the investigator, could complicate the assessment of the results of the trial including pathological deviations from age norms and laboratory norms of blood and urine parameters, which are clinically significant in the opinion of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Petersburg Research Institute of Vaccines and Sera

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellina Ruzanova

Role: STUDY_DIRECTOR

St. Petersburg Research Institute of Vaccines and Sera

Locations

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

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

Moscow, , Russia

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

Perm, , Russia

Baltic Medicine Limited Liability Company (Baltic Medicine LLC)

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

FMK-II/III-02/20

Identifier Type: -

Identifier Source: org_study_id