Clinical trial NCT05297994: Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA
Official title: Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA vs. the Vaxigrip® Inactivated Influenza Split Vaccine Manufactured by Sanofi Pasteur, France, in Volunteers Aged 18-60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: influenza
flu
vaccine
Flu-M
Lead sponsor: St. Petersburg Research Institute of Vaccines and Sera
Sponsor class: OTHER_GOV
First posted: 2022-03-28
Enrollment: 400
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: To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split influenza vaccine in volunteers aged 18-60 years

Detailed description: All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.

Eligibility criteria: Inclusion Criteria:

* Written informed consent of the volunteers to participate in the clinical trial;
* Healthy volunteers (men and women) aged 18-60 years;
* Volunteers able to fulfill requirements of the protocol (fill out the patient's diary, come to follow-up visits);
* If the participant is female, she was required to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception of women of reproductive period)

Exclusion Criteria:

* Allergic reactions to chicken protein or any previous influenza vaccination;
* Leukemia, cancer or a positive reaction to human immunodeficiency virus infection, hepatitis B and C, syphilis in the past medical history;
* Volunteers who received immunoglobulin or blood products within the last 3 months before the trial;
* Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
* Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for 6 months prior to the trial.
* Any confirmed or suspected immunosuppressive or immunodeficiency condition;
* Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests during Visit 1;
* Severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination;
* Being (or having been) a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary;
* acute infectious and/or non-infectious diseases at the time of inclusion in the trial;
* Exacerbation of chronic diseases;
* chronic alcohol abuse and/or use of drugs in the past history;
* Pregnancy and lactation;
* Participation in another clinical trial within the last 3 months;
* Immunization with influenza vaccines in the last 6 months

Primary outcomes:
measure: Severity of observed local reactions and their relationship with the vaccination
timeFrame: days 1-21 post-vaccination
measure: Severity of observed local reactions and their relationship with the vaccination
timeFrame: days 1-21 post-vaccination
measure: Severity of observed local reactions and their relationship with the vaccination
timeFrame: days 1-21 post-vaccination
measure: Severity of observed local reactions and their relationship with the vaccination
timeFrame: days 1-21 post-vaccination
measure: Severity of observed system reactions and their relationship with the vaccination
timeFrame: days 1-21 post-vaccination
measure: Severity of observed system reactions and their relationship with the vaccination
timeFrame: days 1-21 post-vaccination
measure: Severity of observed system reactions and their relationship with the vaccination
timeFrame: days 1-21 post-vaccination
measure: Results of assessment of heart rate (HR)
timeFrame: days 1-21 post-vaccination
measure: Results of assessment of systolic and diastolic blood pressure (BP)
timeFrame: days 1-21 post-vaccination
measure: Results of biochemical blood tests
timeFrame: days 3, 7 and 21
measure: Results of biochemical blood tests
timeFrame: days 3, 7 and 21
measure: Results of biochemical blood tests
timeFrame: days 3, 7 and 21
measure: Results of biochemical blood tests
timeFrame: days 3, 7 and 21
measure: Results of biochemical blood tests
timeFrame: days 3, 7 and 21
measure: Results of complete blood counts
timeFrame: days 3, 7 and 21
measure: Results of complete blood counts
timeFrame: days 3, 7 and 21
measure: Results of complete blood counts
timeFrame: days 3, 7 and 21
measure: Results of complete blood counts
timeFrame: days 3, 7 and 21
measure: Results of complete blood counts
timeFrame: days 3, 7 and 21
measure: Incidence of AEs associated with the vaccination
timeFrame: days 1-21 post-vaccination
measure: Incidence of SAEs associated with the vaccination
timeFrame: days 1-21 post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Infection Center
city: Perm
country: Russian Federation
facility: Perm State Medical University named after Academician E. A. Wagner
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of Influenza
Study officials:
References: