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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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

Inactivated Split Influenza Vaccine

Placebo

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza, flu, vaccine, Flu-M

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Flu-M (without a preservative)

Flu-M (with a preservative)

Placebo

Arm Description

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

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

15 volunteers were treated with a placebo

Outcomes

Primary Outcome Measures

Severity of reported local reactions and their relationship with the vaccination

Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days)

Severity of local reactions reported by participants of the study and their relationship with the vaccination

Severity of system reactions reported by participants of the study and their relationship with the vaccination

The measurement physical data at each visit of the trial site by the volunteer

Secondary Outcome Measures

The immunogenicity assessment of the vaccine was carried out by the seroconversion factor

The immunogenicity assessment of the vaccine was carried out by Geometric mean titer

The immunogenicity assessment of the vaccine was carried out by seroprotection levels

The immunogenicity assessment of the vaccine was carried out by seroconversion

Full Information

NCT ID

NCT05126979

First Posted

September 28, 2021

Last Updated

December 16, 2021

Sponsor

St. Petersburg Research Institute of Vaccines and Sera

1. Study Identification

Unique Protocol Identification Number

NCT05126979

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

March 9, 2016 (Actual)

Primary Completion Date

April 25, 2016 (Actual)

Study Completion Date

May 13, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Petersburg Research Institute of Vaccines and Sera

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

influenza, flu, vaccine, Flu-M

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flu-M (without a preservative)

Arm Type

Experimental

Arm Description

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

Arm Title

Flu-M (with a preservative)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

15 volunteers were treated with a placebo

Intervention Type

Biological

Intervention Name(s)

Inactivated Split Influenza Vaccine

Intervention Type

Biological

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Severity of reported local reactions and their relationship with the vaccination

Time Frame

days 1-7

Title

Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days)

Time Frame

days 1-7

Title

Severity of local reactions reported by participants of the study and their relationship with the vaccination

Time Frame

days 8-20

Title

Severity of system reactions reported by participants of the study and their relationship with the vaccination

Time Frame

days 8-20

Title

The measurement physical data at each visit of the trial site by the volunteer

Time Frame

days 1-20

Secondary Outcome Measure Information:

Title

The immunogenicity assessment of the vaccine was carried out by the seroconversion factor

Time Frame

Measurements will be taken at screening, then up to 21 days post-vaccination

Title

The immunogenicity assessment of the vaccine was carried out by Geometric mean titer

Time Frame

Measurements will be taken at screening, then up to 21 days post-vaccination

Title

The immunogenicity assessment of the vaccine was carried out by seroprotection levels

Time Frame

Measurements will be taken at screening, then up to 21 days post-vaccination

Title

The immunogenicity assessment of the vaccine was carried out by seroconversion

Time Frame

Measurements will be taken at screening, then up to 21 days post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Perm

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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