The Objectives of This Study Are Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years

NCT ID: NCT05126979

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-09
• Study Completion Date: 2016-05-13

Brief Summary

Study of the Reactogenicity, Safety and Immunogenicity of 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: SINGLE

Study Groups

Flu-M (without a preservative)

15 volunteers were treated with the Flu-M inactivated split influenza vaccine without a preservative

Group Type: EXPERIMENTAL

Inactivated Split Influenza Vaccine

Intervention Type: BIOLOGICAL

Flu-M (with a preservative)

15 volunteers were treated with the Flu-M inactivated split influenza vaccine with a preservative

Group Type: EXPERIMENTAL

Inactivated Split Influenza Vaccine

Intervention Type: BIOLOGICAL

Placebo

15 volunteers were treated with a placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Interventions

Inactivated Split Influenza Vaccine

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Written informed consent of the volunteers to participate in the clinical study;
• Healthy volunteers (men and women) aged 18-60 years;
• Volunteers with a titer of antibodies to A(H1N1), A(H3N2) and B influenza viruses less than 1:40 in a HI test
• Volunteers able to fulfill requirements of the protocol (i.e. fill out the patient's diary, come to follow-up visits);
• Female participants were obliged to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception for women of reproductive age)

Exclusion Criteria

• Allergic reactions to chicken protein or any previous influenza vaccination;
• Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history;
• Volunteers who received immunoglobulin or blood products within the last three months before the study;
• Guillain-Barre syndrome (acute polyneuropathy) in the medical history;
• Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the study;
• Any confirmed or suspected immunosuppressive or immunodeficiency condition;
• Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests at 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;
• Volunteers who are (or were) patients 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 study;
• Exacerbation of chronic diseases;
• Alcohol abuse and/or use of drugs in the past history;
• Pregnancy and lactation;
• Participation in another clinical study within the last 3 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

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

Perm, , Russia

Countries

Russia

Other Identifiers

FMV-VGIR-1-001/15

Identifier Type: -

Identifier Source: org_study_id