InfluenzaPhase 2/3NCT05308212
Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra
A Phase 2/3 study testing Flu-M Tetra [Inactivated split influenza vaccine] w/p, Flu-M Tetra [Inactivated split influenza vaccine] w/o/p and Ultrix [Inactivated split influenza vaccine] in people with Influenza, run by St. Petersburg Research Institute of Vaccines and Sera at 11 sites in Russia.
Trial summary
Comparative assessment of the tolerability, safety, and immunogenicity of the FLU-M® Tetra quadrivalent inactivated split influenza vaccine and the Ultrix® vaccine in volunteers aged 60 years and above. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flu-M Tetra [Inactivated split influenza vaccine] w/p, Flu-M Tetra [Inactivated split influenza vaccine] w/o/p and Ultrix [Inactivated split influenza vaccine]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 633 participants
- Where
- 11 sitesRussia
- Study dates
- 4 Mar 2021to 6 Sep 2021
- Phase
- Phase 2/3
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers (men and women) at the age of 60 years and above
- 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;
- History of Guillain-Barré syndrome (acute polyneuropathy);
Show all 23Show fewer
- 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;
- 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, immune and endocrine system, mental disease in the acute stage or in the decompensation stage (recovery less than 4 weeks before vaccination);
- 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, haemophilia;
- Taking aspirin or other antiplatelet agents in high doses.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
State Autonomous Health Institution "Engels City Clinical Hospital No1"
Engel's
Limited Liability Company Professorskaya Clinica
Perm
Limited Liability Company Energia Zdorovya
Saint Petersburg
Limited Liability Company MEDICINSKAYA CLINIKA
Saint Petersburg
Limited Liability Company Scientific Research Center Eco-Bezopasnost
Saint Petersburg
Piramida Limited Liability Company
Saint Petersburg
Private Health Care Institution Clinical Hospital "RZD-Medicine" in Saint Petersburg
Saint Petersburg
Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 117"
Saint Petersburg
Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 43"
Saint Petersburg
Limited Liability Company "DNA Research Center"
Saratov
Federal State Budget Healthcare Institution "Yaroslavl Region Clinical Hospital No. 2"
Yaroslavl
About this study
Official title: Multicenter, Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra Inactivated Vaccine in Volunteers Aged 60 Years and Above
Comparative assessment of the tolerability, safety, and immunogenicity of the FLU-M® Tetra quadrivalent inactivated split influenza vaccine and the Ultrix® vaccine in volunteers aged 60 years and above.
Read the detailed description
Evaluation of the tolerability, safety and immunogenicity of the inactivated split influenza vaccine FLU-M® Tetra compared to Ultrix® vaccine in volunteers aged 60 years and above.
Volunteers were screened and randomized in three groups: the Flu-M Tetra w/p (with preservative) group, the Flu-M Tetra w/o/p (without preservative) group and the Ultrix® group. All subjects were followed up for 28 days post randomization and vaccination.
- Conditions
- Influenza
- Being tested
- Flu-M Tetra [Inactivated split influenza vaccine] w/p, Flu-M Tetra [Inactivated split influenza vaccine] w/o/p, Ultrix [Inactivated split influenza vaccine]
- Keywords
- influenza, flu, vaccine, FLU-M Tetra
- 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 Tetra [Inactivated split influenza vaccine] w/pBiological
solution for intramuscular injection, 0.5 ml
Flu-M Tetra [Inactivated split influenza vaccine] w/o/pBiological
solution for intramuscular injection, 0.5 ml
Ultrix [Inactivated split influenza vaccine]Biological
solution for intramuscular injection, 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| FLU-M Tetra w/p | Experimental | 211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (with preservative) intramuscularly Receives: Biological: Flu-M Tetra [Inactivated split influenza vaccine] w/p |
| FLU-M Tetra w/o/p | Experimental | 211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (without preservative) intramuscularly. Receives: Biological: Flu-M Tetra [Inactivated split influenza vaccine] w/o/p |
| Ultrix | Active comparator | 211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Ultrix vaccine. Receives: Biological: Ultrix [Inactivated split influenza vaccine] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) ratio of antibodies after vaccination
Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated people in haemagglutination inhibition assay.
Measured: days 0, 28
Secondary outcomes (16)
Change from baseline seroconversion rate at 28 days
Seroconversion rate refers to the percentage of subjects who have a prevaccination titer of influenza haemagglutinin antibody titer (HA titer) ≤ 1:10 and a post-vaccination HA titer ≥ 1:40 or a prevaccination HA titer > 1:10 and at least a 4-fold increase in post-vaccination HA titer vs. the baseline.
Measured: days 0, 28
Seroconversion factor
Seroconversion factor is an increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise.
Measured: days 0, 28
Seroprotection rate
Seroprotection rate refers to the percentage of subjects with a generated protective HA titer (at least 1:40) vs. the baseline level.
Measured: days 0, 28
Frequency of development of AEs associated with the vaccination
An adverse event (AE) is any adverse medical occurrence in a trial subject who has received a pharmaceutical product or medicine that does not necessarily have a causal relationship with the medicine.
AE include: new disease, complication of signs or symptoms of the condition being treated or a concomitant disease, effect of the trial drug or the reference drug, effect associated with a trial procedure, any combination of one or more of these factors.
Measured: days 0-28
Frequency of development of SAEs associated with the vaccination
An adverse event is considered serious if it is fatal, threatens the life, requires hospitalization or extension of hospitalization, results in permanent or significant disability, is a congenital abnormality or defect (not applicable to this trial), is an important medical event.
Measured: days 0-28
Number of participants with abnormal physical examination findings
Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion for the following organs and systems: skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system, endocrine system.
Measured: days 0,1,3,7,28
Results of assessment of blood pressure (BP)
BP measurements include the systolic and diastolic blood pressure.
Measured: days 0,1,3,7,28
Results of assessment of heart rate (HR)
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 0,1,3,7,28
Results of E immunoglobulin tests
Determination of total IgE.
Measured: days 0,3,28
Results of assessment of respiratory rate (RR)
RR is measured for a minute at rest in the sitting position, by registering the breathing movements of the chest or abdominal wall, without attracting the patient's attention.
Measured: days 0,1,3,7,28
Results of assessment of body temperature
Body temperature 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 0,1,3,7,28
Number of participants with abnormal neurological examinations
Assessement of neurological status, cranial nerve function, motor sphere, reflex sphere, sensitive sphere, coordination sphere, pelvic functions, higher mental functions.
Measured: days 0,1,3,7,28
Number of participants with abnormal ECG findings
ECG QT Interval, QTc Interval, PQ Interval, QRS complex.
Measured: days 0,3
Number of participants with abnormal complete blood counts results
Hemoglobin, hematocrit, erythrocytes, leukocytes, platelets, leukocyte count, ESR.
Measured: days 0,3
Number of participants with abnormal biochemical blood tests results
Total protein, creatinine, urea, glucose, total bilirubin, total cholesterol, AST, ALT, ALP.
Measured: days 0,3
Number of participants with abnormal urinalysis results
pH, specific gravity, protein, glucose, red blood cells, white blood cells
Measured: days 0,3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start4 Mar 2021
- Primary completion30 Jul 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and Sera
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308212
- Sponsor's protocol ID
- FLM-TE-04-2020
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra Inactivated Vaccine in Volunteers Aged 60 Years and Above
- ClinicalTrials.gov ID
- NCT05308212
- Acronym / sponsor ID
- FLM-TE-04-2020
- Conditions
- Influenza
- Keywords
- influenza, flu, vaccine, FLU-M Tetra
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and SeraOther government
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative assessment of the tolerability, safety, and immunogenicity of the FLU-M® Tetra quadrivalent inactivated split influenza vaccine and the Ultrix® vaccine in volunteers aged 60 years and above.
Detailed description
Evaluation of the tolerability, safety and immunogenicity of the inactivated split influenza vaccine FLU-M® Tetra compared to Ultrix® vaccine in volunteers aged 60 years and above.
Volunteers were screened and randomized in three groups: the Flu-M Tetra w/p (with preservative) group, the Flu-M Tetra w/o/p (without preservative) group and the Ultrix® group. All subjects were followed up for 28 days post randomization and vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FLU-M Tetra w/p | Experimental | Biological: Flu-M Tetra [Inactivated split influenza vaccine] w/p211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (with preservative) intramuscularly |
| FLU-M Tetra w/o/p | Experimental | Biological: Flu-M Tetra [Inactivated split influenza vaccine] w/o/p211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (without preservative) intramuscularly. |
| Ultrix | Active comparator | Biological: Ultrix [Inactivated split influenza vaccine]211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Ultrix vaccine. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers (men and women) at the age of 60 years and above
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flu-M Tetra [Inactivated split influenza vaccine] w/psolution for intramuscular injection, 0.5 ml | Biological | FLU-M Tetra w/p |
| Flu-M Tetra [Inactivated split influenza vaccine] w/o/psolution for intramuscular injection, 0.5 ml | Biological | FLU-M Tetra w/o/p |
| Ultrix [Inactivated split influenza vaccine]solution for intramuscular injection, 0.5 ml | Biological | Ultrix |
Primary outcome
Geometric mean titer (GMT) ratio of antibodies after vaccination
Time frame: days 0, 28
Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated people in haemagglutination inhibition assay.
16 secondary outcomes
Change from baseline seroconversion rate at 28 days
Time frame: days 0, 28
Seroconversion factor
Time frame: days 0, 28
Seroprotection rate
Time frame: days 0, 28
Frequency of development of AEs associated with the vaccination
Time frame: days 0-28
Frequency of development of SAEs associated with the vaccination
Time frame: days 0-28
Number of participants with abnormal physical examination findings
Time frame: days 0,1,3,7,28
Results of assessment of blood pressure (BP)
Time frame: days 0,1,3,7,28
Results of assessment of heart rate (HR)
Time frame: days 0,1,3,7,28
Results of E immunoglobulin tests
Time frame: days 0,3,28
Results of assessment of respiratory rate (RR)
Time frame: days 0,1,3,7,28
Results of assessment of body temperature
Time frame: days 0,1,3,7,28
Number of participants with abnormal neurological examinations
Time frame: days 0,1,3,7,28
Number of participants with abnormal ECG findings
Time frame: days 0,3
Number of participants with abnormal complete blood counts results
Time frame: days 0,3
Number of participants with abnormal biochemical blood tests results
Time frame: days 0,3
Number of participants with abnormal urinalysis results
Time frame: days 0,3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Flu-M Tetra [Inactivated split influenza vaccine] w/p, Flu-M Tetra [Inactivated split influenza vaccine] w/o/p and Ultrix [Inactivated split influenza vaccine] in people with Influenza, run by St. Petersburg Research Institute of Vaccines and Sera at 11 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 23 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Geometric mean titer (GMT) ratio of antibodies after vaccination (time frame: days 0, 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2022.