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InfluenzaPhase 3NCT05312294

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

A Phase 3 study testing Flu-M [inactivated split influenza vaccine] without preservative and Flu-M [inactivated split influenza vaccine] with preservative in people with Influenza and Flu, Human, run by St. Petersburg Research Institute of Vaccines and Sera at 8 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Flu, Human
What is being tested?
Flu-M [inactivated split influenza vaccine] without preservative and Flu-M [inactivated split influenza vaccine] with preservative
Could I receive a placebo?
No, everyone receives an active treatment
How many people
654 participants
Where
8 sitesRussia
Study dates
7 Dec 2020to 15 Nov 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers (men and women) aged 18-60 years;
  • Written informed consent of volunteers to participate in the clinical trial;
  • Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's diary, come to follow-up visits);
  • 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
  • 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.

Who cannot join

  • History of influenza/ARVI or previous influenza vaccination during 6 months before the trial;
  • Positive result of the SARS-CoV-2 test;
  • 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);
  • Allergic reactions to vaccine components or any previous vaccination;
  • History of allergic reaction to chicken protein;
  • Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
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  • 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;
  • Use of any vaccines within 1 month before the vaccination, excluding vaccines according to the National Calendar of Preventive Vaccination, including for epidemic reasons;
  • History of leukemia, cancer, autoimmune diseases;
  • (Positive blood test results for HIV, syphilis, hepatitis B/C;
  • Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;
  • History of long-term use (more than 14 days) of immunosuppressants or immunomodulatory drugs for six months before the trial;
  • History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
  • 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);
  • Diabetes mellitus, thyrotoxicosis or other diseases of the endocrine system;
  • History of eczema;
  • 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);
  • Tuberculosis, neurological or mental disorders, a convulsive syndrome, including in the past medical history;
  • History of acute infectious diseases (recovery less than 4 weeks before vaccination);
  • Consumption of more than 10 units of alcohol per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products;
  • Smoking of more than 10 cigarettes per day;
  • Participation in another clinical trial during the last 3 months;
  • Pregnancy or lactation;
  • Coagulopathy, including hemophilia;
  • Taking aspirin or other antiplatelet agents in high doses.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Russia8 sites

  • State Autonomous Health Institution "Engels City Clinical Hospital No1"

    Engel's

  • Limited Liability Company "Professorskaya Clinica"

    Perm

  • Limited Liability Company "Clinika Zvezdnaya"

    Saint Petersburg

  • Limited Liability Company "MEDICINSKAYA CLINIKA"

    Saint Petersburg

  • Limited Liability Company "PeterClinic"

    Saint Petersburg

  • Limited Liability Company "Scientific Research Center Eco-Safety"

    Saint Petersburg

  • Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 117"

    Saint Petersburg

  • Limited Liability Company "Medical Center Diagnostics and Prevention Plus"

    Yaroslavl

Other trials in Russia

About this study

Official title: 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

Read the 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.

Being tested
Flu-M [inactivated split influenza vaccine] without preservative, Flu-M [inactivated split influenza vaccine] with preservative
Keywords
Influenza, Flu, Vaccine, FLU-M, SPbSRIVS
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flu-M [inactivated split influenza vaccine] without preservativeBiological

    Solution for intramuscular injection, 0.5 ml

  • Flu-M [inactivated split influenza vaccine] with preservativeBiological

    Solution for intramuscular injection, 0.5 ml

Study groups in NCT05312294
Study groupRoleWhat they receive
FLU-M w/o/pExperimentalVolunteers were vaccinated with a single dose of the Flu-M vaccine (without preservative) intramuscularly in a dose of 0.5 mL.
Receives: Biological: Flu-M [inactivated split influenza vaccine] without preservative
FLU-M w/pExperimentalVolunteers were vaccinated with a single dose of the Flu-M vaccine (with preservative) intramuscularly in a dose of 0.5 mL.
Receives: Biological: Flu-M [inactivated split influenza vaccine] with preservative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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

    Measured: days 0-180

  2. Change from baseline the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) at 6 months

    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%

    Measured: days 0-180

Secondary outcomes (15)

  1. Geometric mean titer of antibodies for each virus strain (A (H1N1), A (H3N2) and B)

    Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay)

    Measured: days 0,28,180

  2. Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)

    Measured: days 0,28,180

  3. Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)

    Measured: days 0,28,180

  4. Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)

    Measured: days 0,28,180

  5. Incidence, severity, and duration of influenza or ARVI during 6 months after vaccination

    Measured: days 1-180

  6. Incidence of adverse events (AEs)

    Measured: days 1-180

  7. Incidence of serious adverse events (SAEs)

    Measured: days 1-180

  8. Number of patients with abnormal results of blood pressure (BP)

    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.

    Measured: days 0,1,7,28,180

  9. Number of patients with abnormal results of heart rate (HR)

    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.

    Measured: days 0,1,7,28,180

  10. Number of patients with abnormal results of respiratory rate (RR)

    The RR is measured for a minute at rest in the sitting position, by registering the breathing movements of the chest or abdominal wall.

    Measured: days 0,1,7,28,180

  11. Number of patients with abnormal results of body temperature (>37 °С)

    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.

    Measured: days 0,1,7,28,180

  12. Number of patients with abnormal results of physical examination

    Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion.

    Measured: days 0,1,7,28,180

  13. Number of patients with abnormal results of neurological status

    Assessment of:

    • Cranial nerve function
    • Motor sphere
    • Reflex sphere
    • Sensitive sphere
    • Coordination sphere
    • Pelvic functions
    • Higher mental functions

    Measured: days 0,7,28

  14. Determination of total IgE

    Measured: days 0,7,28

  15. Number of patients with abnormal results of electrocardiography (ECG)

    2-lead electrocardiography (ECG). Assessment of: PQ, QT,QTc intervals, QRS complex

    Measured: days 0,7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start7 Dec 2020
  3. Primary completion3 Sep 2021
  4. Study completion15 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312294
Sponsor's protocol ID
FLM-03-2020
Status last verified
Mar 2022
First submitted
17 Mar 2022
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Flu-M [inactivated split influenza vaccine] without preservative and Flu-M [inactivated split influenza vaccine] with preservative in people with Influenza and Flu, Human, run by St. Petersburg Research Institute of Vaccines and Sera at 8 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05312294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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