Clinical trial NCT05869201: Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine
Official title: Double-blind Comparative Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, FSUE SPbSRIVS FMBA of Russia, in Volunteers Aged 18-60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: St. Petersburg Research Institute of Vaccines and Sera
Sponsor class: OTHER_GOV
First posted: 2023-05-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: Screening (Days 0+5), Day 28
Secondary outcomes:
measure: 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))
timeFrame: Screening (Days 0+5), Day 28
measure: 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
timeFrame: Screening (Days 0+5), Day 28
measure: 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
timeFrame: Screening (Days 0+5), Day 28
measure: Incidence of influenza and ARVI
timeFrame: During 6 months after vaccination
measure: Incidence of immediate adverse events (allergic reactions)
timeFrame: 2 hours after vaccination
measure: Incidence of local adverse events
timeFrame: 7 days after vaccination
measure: Incidence of systemic adverse events
timeFrame: 7 days after vaccination
measure: Incidence of other adverse reactions
timeFrame: Days 8 to 28 after vaccination
measure: Incidence of severe adverse events
timeFrame: Days 1 to 28 after vaccination
measure: Incidence of withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products
timeFrame: Days 1-7, 14
measure: Number of participants with abnormal physical examination findings
timeFrame: Screening (Days 0+5), Days 1-7, 14, 28
measure: Number of participants with abnormal changes in vital signs - Blood pressure (BP)
timeFrame: Screening (Days 0+5), Days 1-7, 14, 28
measure: Number of participants with abnormal changes in vital signs - Heart rate (HR)
timeFrame: Screening (Days 0+5), Days 1-7, 14, 28
measure: Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
timeFrame: Screening (Days 0+5), Days 1-7, 14, 28
measure: Number of participants with abnormal changes in vital signs - Body temperature
timeFrame: Screening (Days 0+5), Day 1 - before vaccination, 20 minutes and 2, 5-8 hours after vaccination; Days 2-7, 14, 28
measure: Number of participants with clinically significant abnormalities - Complete blood count (CBC)
timeFrame: Screening (Days 0+5), Days 3, 14, 28
measure: Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
timeFrame: Screening (Days 0+5), Days 3, 14, 28
measure: Number of participants with clinically significant abnormalities - Urinalysis
timeFrame: Screening (Days 0+5), Days 3, 14, 28
measure: Number of participants with abnormal changes of total IgE
timeFrame: Screening (Days 0+5), Days 3, 14, 28
measure: Number of participants with abnormal neurological examinations
timeFrame: Screening (Days 0+5), Days 1, 3 (When the interval between the screening visit and visit 1 is more than 3 days), 14, 28
measure: Number of participants with abnormal electrocardiography results
timeFrame: Screening (Days 0+5), Day 3
Other outcomes:
Locations:
city: Kol'tsovo
country: Russian Federation
facility: Federally Funded Healthcare Institution Primary Healthcare Unit No. 163,of Federal Medical and Biologic Agency (FFHI PHU No. 163, FMBA of Russia)
state: Novosibirsk Region
city: Moscow
country: Russian Federation
facility: Bessalar Clinic. Clinical Trial Center Limited Liability Company (Bessalar Clinic. Clinical Trial Center LLC)
city: Perm
country: Russian Federation
facility: Federation (FSBEI of Higher Education "E. A. Wagner PSMU" of the of the Ministry of Health of the Russian Federation)
city: Saint-Petersburg
country: Russian Federation
facility: Baltic Medicine Limited Liability Company (Baltic Medicine LLC)
city: Saint-Petersburg
country: Russian Federation
facility: Eco-Safety Scientific Research and Development Center Limited Liability Company (Eco-Safety Scientific Research and Development Center LLC)
Study officials:
affiliation: St. Petersburg Research Institute of Vaccines and Sera
name: Ellina Ruzanova
role: STUDY_DIRECTOR
References: