Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA

St. Petersburg Research Institute of Vaccines and Sera

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Flu-M [Inactivated split influenza vaccine]

Biological: Inactivated influenza split vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT05297994

FMV-VGIR-II-001/16

Details and patient eligibility

About

To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split influenza vaccine in volunteers aged 18-60 years

Full 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.

Enrollment

400 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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