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

NCT ID: NCT05297994

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-24
• Study Completion Date: 2017-03-09

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.

Conditions

Influenza

Study Design

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

Study Groups

Flu-M

200 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative

Group Type: EXPERIMENTAL

Flu-M [Inactivated split influenza vaccine]

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Vaxigrip

200 volunteers were vaccinated with the Vaxigrip® inactivated split influenza vaccine

Group Type: ACTIVE_COMPARATOR

Inactivated influenza split vaccine

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Interventions

Flu-M [Inactivated split influenza vaccine]

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Inactivated influenza split vaccine

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

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

• 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

Locations

Infection Center

Novosibirsk, , Russia

Perm State Medical University named after Academician E. A. Wagner

Perm, , Russia

Research Institute of Influenza

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

FMV-VGIR-II-001/16

Identifier Type: -

Identifier Source: org_study_id