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

December 16, 2021 updated by: St. Petersburg Research Institute of Vaccines and Sera

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Perm, Russian Federation
        • Perm State Medical University named after Academician E.A. Wagner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Flu-M (without a preservative)
15 volunteers were treated with the Flu-M inactivated split influenza vaccine without a preservative
Biological: Inactivated Split Influenza Vaccine
Experimental: Flu-M (with a preservative)
15 volunteers were treated with the Flu-M inactivated split influenza vaccine with a preservative
Biological: Inactivated Split Influenza Vaccine
Placebo Comparator: Placebo
15 volunteers were treated with a placebo
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Severity of reported local reactions and their relationship with the vaccination
Time Frame: days 1-7
days 1-7
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
days 1-7
Severity of local reactions reported by participants of the study and their relationship with the vaccination
Time Frame: days 8-20
days 8-20
Severity of system reactions reported by participants of the study and their relationship with the vaccination
Time Frame: days 8-20
days 8-20
The measurement physical data at each visit of the trial site by the volunteer
Time Frame: days 1-20
days 1-20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Measurements will be taken at screening, then up to 21 days post-vaccination
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
Measurements will be taken at screening, then up to 21 days post-vaccination
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
Measurements will be taken at screening, then up to 21 days post-vaccination
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
Measurements will be taken at screening, then up to 21 days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Petersburg Research Institute of Vaccines and Sera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMV-VGIR-1-001/15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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