Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years

March 28, 2022 updated by: St. Petersburg Research Institute of Vaccines and Sera

Multicenter, Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years

Comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M® Inactivated Split Influenza Vaccine (without preservative) and the Flu-M® vaccine (with preservative) in volunteers aged between 18 and 60

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

  1. Assessment of the tolerability and safety of the Flu-M® inactivated split influenza vaccine (without preservative) and Flu-M® (with preservative).
  2. Assessment of the immunogenicity of the Flu-M® inactivated split influenza vaccine (with preservative) and Flu-M® (without preservative).

Single administration of the trial products. Duration of follow-up - 28+3 (outpatient visit) and Long-term follow-up - 180±3 days.

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.
654

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 3

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
      • Engels, Russian Federation
        • State Autonomous Health Institution "Engels City Clinical Hospital No1"
      • Perm, Russian Federation
        • Limited Liability Company "Professorskaya Clinica"
      • Saint Petersburg, Russian Federation
        • Limited Liability Company "Clinika Zvezdnaya"
      • Saint Petersburg, Russian Federation
        • Limited Liability Company "MEDICINSKAYA CLINIKA"
      • Saint Petersburg, Russian Federation
        • Limited Liability Company "PeterClinic"
      • Saint Petersburg, Russian Federation
        • Limited Liability Company "Scientific Research Center Eco-Safety"
      • Saint Petersburg, Russian Federation
        • Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 117"
      • Yaroslavl, Russian Federation
        • Limited Liability Company "Medical Center Diagnostics and Prevention Plus"

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:

  1. Healthy volunteers (men and women) aged 18-60 years;
  2. Written informed consent of volunteers to participate in the clinical trial;
  3. Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's diary, come to follow-up visits);
  4. For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination
  5. For fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years.

Exclusion Criteria:

  1. History of influenza/ARVI or previous influenza vaccination during 6 months before the trial;
  2. Positive result of the SARS-CoV-2 test;
  3. A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
  4. Allergic reactions to vaccine components or any previous vaccination;
  5. History of allergic reaction to chicken protein;
  6. Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
  7. Previous vaccination with rabies vaccines less than 2 months before immunization or scheduled vaccination with rabies vaccines within 1 month after immunization with the trial vaccines;
  8. Use of any vaccines within 1 month before the vaccination, excluding vaccines according to the National Calendar of Preventive Vaccination, including for epidemic reasons;
  9. History of leukemia, cancer, autoimmune diseases;
  10. (Positive blood test results for HIV, syphilis, hepatitis B/C;
  11. Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;
  12. History of long-term use (more than 14 days) of immunosuppressants or immunomodulatory drugs for six months before the trial;
  13. History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
  14. History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, the gastrointestinal tract, liver, kidneys, hematopoietic or immune systems, mental disease in the acute stage or in the decompensation stage (recovery less than 4 weeks before vaccination);
  15. Diabetes mellitus, thyrotoxicosis or other diseases of the endocrine system;
  16. History of eczema;
  17. Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (> 10 mg of prednisolone or its equivalent for more than 14 days before the screening);
  18. Tuberculosis, neurological or mental disorders, a convulsive syndrome, including in the past medical history;
  19. History of acute infectious diseases (recovery less than 4 weeks before vaccination);
  20. Consumption of more than 10 units of alcohol per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products;
  21. Smoking of more than 10 cigarettes per day;
  22. Participation in another clinical trial during the last 3 months;
  23. Pregnancy or lactation;
  24. Coagulopathy, including hemophilia;
  25. Taking aspirin or other antiplatelet agents in high doses.

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: Double

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 w/o/p
Volunteers were vaccinated with a single dose of the Flu-M vaccine (without preservative) intramuscularly in a dose of 0.5 mL.
Biological: Flu-M [inactivated split influenza vaccine] without preservative
Solution for intramuscular injection, 0.5 ml
Experimental: FLU-M w/p
Volunteers were vaccinated with a single dose of the Flu-M vaccine (with preservative) intramuscularly in a dose of 0.5 mL.
Biological: Flu-M [inactivated split influenza vaccine] with preservative
Solution for intramuscular injection, 0.5 ml

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
Measure Description
Time Frame
Change from baseline geometric mean titer ratio of antibodies for each virus strain (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) at 6 months
Time Frame: days 0-180
The upper limit of bilateral 95% CI for the GMT ratio (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) should not exceed 1.5
days 0-180
Change from baseline the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) at 6 months
Time Frame: days 0-180
The upper limit of bilateral 95% CI for the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) should not exceed 10%
days 0-180

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
Measure Description
Time Frame
Geometric mean titer of antibodies for each virus strain (A (H1N1), A (H3N2) and B)
Time Frame: days 0,28,180
Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay)
days 0,28,180
Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)
Time Frame: days 0,28,180
days 0,28,180
Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)
Time Frame: days 0,28,180
days 0,28,180
Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)
Time Frame: days 0,28,180
days 0,28,180
Incidence, severity, and duration of influenza or ARVI during 6 months after vaccination
Time Frame: days 1-180
days 1-180
Incidence of adverse events (AEs)
Time Frame: days 1-180
days 1-180
Incidence of serious adverse events (SAEs)
Time Frame: days 1-180
days 1-180
Number of patients with abnormal results of blood pressure (BP)
Time Frame: days 0,1,7,28,180
BP measurements include the systolic and diastolic blood pressure.BP is measured on the brachial artery according to the Korotkoff method using a certified sphygmomanometer or tonometer. It is also allowed to use a certified electronic tonometer for measuring.
days 0,1,7,28,180
Number of patients with abnormal results of heart rate (HR)
Time Frame: days 0,1,7,28,180
The HR is measured during auscultation of the heart in parallel with determining the pulse rate on the radial artery (or on the carotid artery in case of weak pulsation in the radial artery) for a minute while sitting.
days 0,1,7,28,180
Number of patients with abnormal results of respiratory rate (RR)
Time Frame: days 0,1,7,28,180
The RR is measured for a minute at rest in the sitting position, by registering the breathing movements of the chest or abdominal wall.
days 0,1,7,28,180
Number of patients with abnormal results of body temperature (>37 °С)
Time Frame: days 0,1,7,28,180
Body temperature (°C) is measured with a mercury or digital thermometer in the armpit for at least 5 minutes or with a non-contact infrared digital thermometer.
days 0,1,7,28,180
Number of patients with abnormal results of physical examination
Time Frame: days 0,1,7,28,180
Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion.
days 0,1,7,28,180
Number of patients with abnormal results of neurological status
Time Frame: days 0,7,28

Assessment of:

  • Cranial nerve function
  • Motor sphere
  • Reflex sphere
  • Sensitive sphere
  • Coordination sphere
  • Pelvic functions
  • Higher mental functions
days 0,7,28
Determination of total IgE
Time Frame: days 0,7,28
days 0,7,28
Number of patients with abnormal results of electrocardiography (ECG)
Time Frame: days 0,7
2-lead electrocardiography (ECG). Assessment of: PQ, QT,QTc intervals, QRS complex
days 0,7

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.
December 7, 2020

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.
September 3, 2021

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.
November 15, 2021

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).
March 17, 2022

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.
March 28, 2022

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.
April 5, 2022

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.
April 5, 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.
March 28, 2022

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.
March 1, 2022

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.
  • FLM-03-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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