Influenza, HumanPhase 3NCT05470582

Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

A Phase 3 study testing Flu-M, Inactivated split influenza vaccine 0.5 mL, Vaxigrip, Inactivated split influenza vaccine 0.5 mL and Flu-M, Inactivated split influenza vaccine 0.25 mL in people with Influenza, Human and Vaccination; Infection, run by St. Petersburg Research Institute of Vaccines and Sera at 2 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 trial of tolerability, reactogenicity, safety and immunogenicity of the Flu-M vaccine as compared to the Vaxigrip® vaccine in terms of prevention of influenza in children aged 6 months to 9 years (at the time of the first vaccination). Read more about this study

Who is it for?: Ages 6 months to 9 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Human, Vaccination; Infection, Vaccines
What is being tested?: Flu-M, Inactivated split influenza vaccine 0.5 mL, Vaxigrip, Inactivated split influenza vaccine 0.5 mL and Flu-M, Inactivated split influenza vaccine 0.25 mL
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,066 participants
Where: 2 sitesRussia
Study dates: 16 Feb 2021to 24 Dec 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 6 months to 9 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

For volunteers aged 3 to 9 years:
Healthy children of both sexes aged 3 to 9 years (3 years 0 months 0 days - 8 years 11 months 30 days);
The written and dated informed consent of one of the parents for participation in the trial;
For volunteers aged 6 to 35 months:
Healthy children of both genders aged 6 to 35 months, inclusive (6 months 0 days - 35 months 30 days);
The written and dated informed consent of one of the parents for participation in the trial;

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The trial subject of the was born full-term, with the Apgar score of 7-10 points.
For all volunteers:
Ability of a volunteer's parents to fulfill the requirements of the Protocol (i.e. to fill out the Patient Diary, come to visit with the volunteer).

Who cannot join

History of influenza (including in mothers for children aged 6 to 35 months) or previous influenza vaccination during 6 months before the trial;
Positive result of the SARS-CoV-2 test;
Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine;
Vaccination with any vaccine less than 30 days before participating in the trial or scheduled vaccination with any vaccine within 30 days after vaccination with the trial vaccines;
A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter at the injection site) 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), encephalopathy;
Allergic reactions to vaccine components or any previous vaccination;

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History of allergic reaction to chicken protein;
History of cancer, leukemia, tuberculosis, autoimmune diseases;
Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents;
Children who received immunoglobulin products or transfusions of whole blood or its components less than 3 months before the start of the trial;
Long-term use (more than 14 days) of any immunomodulating medicines less than 3 months before the start of the trial;
Any confirmed or suspected immunosuppressive or immunodeficiency condition;
History of chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, blood in the acute stage (recovery less than 4 weeks before vaccination) or in the decompensation stage;
Children with hemophilia who may develop bleeding after intramuscular injection;
History of progressive neurological pathology, convulsive syndrome, afebrile convulsions;
History of acute infectious diseases (fever ≥ 37.5°С): recovery less than 2 weeks before vaccination;
Participation in another clinical trial less than 3 months before the start of the trial;
History of mental illness of the child and the volunteer's parents;
The history of the volunteer's parent being registered with a tuberculosis dispensary and/or a narcological dispensary;
Maternal history of drug use or alcohol abuse during pregnancy and/or breastfeeding;
Pronounced congenital malformations in a child;
Suspected developmental delay in a child.

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

LLC "Energiya zdorov'ya"
Saint Petersburg
St. Petersburg State Budgetary Institution of Health Care "Children's City Polyclinic No. 45" of the Nevsky District
Saint Petersburg

Other trials in Russia

About this study

Official title: Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

Read the detailed description

The trial includes 2 stages (stage I, II). At stage I children aged 3-9 years will be included. Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Vaxigrip® vaccine for the first 7 days after vaccination of volunteers during Stage I, an intermediate report will be prepared. The report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II of the trial - the continuation of trial on children aged 3-9 years and the commencement of trial on children aged between 6 months and 35 months. During Stage II, the trial for Stage I volunteers will continue in full and also children aged between 6 and 35 months will be included in the trial.

Conditions: Influenza, Human, Vaccination; Infection, Vaccines
Being tested: Flu-M, Inactivated split influenza vaccine 0.5 mL, Vaxigrip, Inactivated split influenza vaccine 0.5 mL, Flu-M, Inactivated split influenza vaccine 0.25 mL, Vaxigrip, Inactivated split influenza vaccine 0.25 mL
Keywords: Influenza, Flu, Vaccine, FLU-M, SPbSRIVS, Vaxigrip, Children
Medical subject headings: Influenza, Human, Infections

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 0.5 mLBiological
Solution for intramuscular injection Сhildren were vaccinated with the Flu-M vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL
Vaxigrip, Inactivated split influenza vaccine 0.5 mLBiological
Suspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL
Flu-M, Inactivated split influenza vaccine 0.25 mLBiological
Solution for intramuscular injection Children were vaccinated with the Flu-M vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL
Vaxigrip, Inactivated split influenza vaccine 0.25 mLBiological
Suspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL

Study groups in NCT05470582
Study group	Role	What they receive
Flu-M, children aged 3-9 years	Experimental	Not described Receives: Biological: Flu-M, Inactivated split influenza vaccine 0.5 mL
Vaxigrip, children aged 3-9 years	Active comparator	Not described Receives: Biological: Vaxigrip, Inactivated split influenza vaccine 0.5 mL
Flu-M, children aged 6-35 months	Experimental	Not described Receives: Biological: Flu-M, Inactivated split influenza vaccine 0.25 mL
Vaxigrip, children aged 6-35 months	Active comparator	Not described Receives: Biological: Vaxigrip, Inactivated split influenza vaccine 0.25 mL

What is being measured

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

Change from Baseline seroconversion level
Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay) The upper limit of bilateral 95 % CI for the difference between seroconversion levels (seroconversion level reference vaccine - the seroconversion level trial vaccine) should not exceed 10%.
Seroconversion ≥ 40%
Measured: Days 0 (screening), 28, 56, 180 after vaccination/revaccination

Secondary outcomes (18)

Change from Baseline Geometric mean titer (GMT) of antibodies
Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay) The upper limit of bilateral 95% CI for the GMT ratio (GMTreference vaccine/GMTtrial vaccine) should not exceed 1.5
Measured: Days 0 (screening), 28 after vaccination/revaccination
Change from Baseline Seroconversion factor
Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay) Seroconversion factor ≥ 2.5
Measured: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
Change from Baseline Seroprotection rate
Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay) Seroprotection ≥ 70%
Measured: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
Change from Baseline Seroconversion rate for each virus strain
Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay)
Measured: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
Incidence of immediate adverse events (allergic reactions)
Anaphylaxis, Quincke's edema, Urticaria.
Measured: 2 hours after vaccination/revaccination
Incidence of local adverse events
Pain at the injection site at palpation, Hyperemia at the injection site, infiltrate at the injection site, Edema at the injection site, Pruritus at the injection site, Enlarged regional lymph nodes.
Measured: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
Incidence of systemic adverse events
Headache, Cough, Sore throat, Nausea, Increased sweating, Arthralgia, Myalgia, Fever, Chills, Asthenia
Measured: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
Incidence of severe adverse events during the trial
Measured: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
Number of participants with abnormal changes in physical examination data
Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion; examination of skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, heart/cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system.
Measured: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes of neurological status
Measured: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes in vital signs - Blood pressure (BP)
BP measurements include the systolic and diastolic blood pressure.
Measured: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes in vital signs - Heart rate (HR)
HR is measured using a phonendoscope at the apex of the heart during 1 minute.
Measured: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
RR is counted with a hand placed on the child's chest or abdomen or by holding a stethoscope at the child's nose. The measurement is carried out during one minute.
Measured: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes in vital signs - Body temperature
Measurement with a digital thermometer.
Measured: Day 0 (screening); 10 min before, 20 min and 2 hours after vaccination; days 3, 7, 28, 56
Number of participants with clinically significant abnormalities - Complete blood count (CBC)
Hemoglobin, hematocrit, erythrocytes, leukocytes, leukocytic formula, platelets, erythrocyte sedimentation rate (ESR).
Measured: Days 0 (screening), 3
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
ALT, AST, LDH, alkaline phosphatase, total bilirubin, urea, glucose.
Measured: Days 0 (screening), 3
Number of participants with clinically significant abnormalities - Urinalysis
pH, specific density, protein, glucose, erythrocytes, leukocytes.
Measured: Days 0 (screening), 3
Number of participants with abnormal changes of total IgE
Measured: Days 0 (screening), 3, 56

Timeline

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

16 Feb 202124 Dec 2021

First posted22 Jul 2022
Study start16 Feb 2021
Primary completion29 Oct 2021
Study completion24 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Influenza, HumanStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,066 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05470582
Sponsor's protocol ID: FLM-04-2020
Status last verified: Jul 2022
First submitted: 19 Jul 2022
Last updated: 22 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old
ClinicalTrials.gov ID: NCT05470582
Acronym / sponsor ID: FLM-04-2020
Conditions: Influenza, Human, Vaccination; Infection, Vaccines
Keywords: Influenza, Flu, Vaccine, FLU-M, SPbSRIVS, Vaxigrip, Children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,066 participants (actual)
Lead sponsor: St. Petersburg Research Institute of Vaccines and SeraOther government
Study start: 16 Feb 2021 (actual)
Primary completion: 29 Oct 2021 (actual)
Study completion: 24 Dec 2021 (actual)
First posted: 22 Jul 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Flu-M, children aged 3-9 years	Experimental	Biological: Flu-M, Inactivated split influenza vaccine 0.5 mL
Vaxigrip, children aged 3-9 years	Active comparator	Biological: Vaxigrip, Inactivated split influenza vaccine 0.5 mL
Flu-M, children aged 6-35 months	Experimental	Biological: Flu-M, Inactivated split influenza vaccine 0.25 mL
Vaxigrip, children aged 6-35 months	Active comparator	Biological: Vaxigrip, Inactivated split influenza vaccine 0.25 mL

Who may qualify

Ages: 6 months to 9 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (9 listed)

For volunteers aged 3 to 9 years:
For volunteers aged 6 to 35 months:
For all volunteers:
Ability of a volunteer's parents to fulfill the requirements of the Protocol (i.e. to fill out the Patient Diary, come to visit with the volunteer).

Key exclusion criteria (22 listed)

History of influenza (including in mothers for children aged 6 to 35 months) or previous influenza vaccination during 6 months before the trial;
Positive result of the SARS-CoV-2 test;
Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine;
Vaccination with any vaccine less than 30 days before participating in the trial or scheduled vaccination with any vaccine within 30 days after vaccination with the trial vaccines;
A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter at the injection site) 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), encephalopathy;

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, Inactivated split influenza vaccine 0.5 mLSolution for intramuscular injection Сhildren were vaccinated with the Flu-M vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL	Biological	Flu-M, children aged 3-9 years
Vaxigrip, Inactivated split influenza vaccine 0.5 mLSuspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL	Biological	Vaxigrip, children aged 3-9 years
Flu-M, Inactivated split influenza vaccine 0.25 mLSolution for intramuscular injection Children were vaccinated with the Flu-M vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL	Biological	Flu-M, children aged 6-35 months
Vaxigrip, Inactivated split influenza vaccine 0.25 mLSuspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL	Biological	Vaxigrip, children aged 6-35 months

Primary outcome

Change from Baseline seroconversion level
Time frame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
Specific anti-influenza antibodies were determined using haemagglutination inhibition assay (HI assay) The upper limit of bilateral 95 % CI for the difference between seroconversion levels (seroconversion level reference vaccine - the seroconversion level trial vaccine) should not exceed 10%. Seroconversion ≥ 40%

18 secondary outcomes

Change from Baseline Geometric mean titer (GMT) of antibodies
Time frame: Days 0 (screening), 28 after vaccination/revaccination
Change from Baseline Seroconversion factor
Time frame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
Change from Baseline Seroprotection rate
Time frame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
Change from Baseline Seroconversion rate for each virus strain
Time frame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
Incidence of immediate adverse events (allergic reactions)
Time frame: 2 hours after vaccination/revaccination
Incidence of local adverse events
Time frame: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
Incidence of systemic adverse events
Time frame: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
Incidence of severe adverse events during the trial
Time frame: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
Number of participants with abnormal changes in physical examination data
Time frame: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes of neurological status
Time frame: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes in vital signs - Blood pressure (BP)
Time frame: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes in vital signs - Heart rate (HR)
Time frame: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
Time frame: Days 0 (screening), 3, 7, 28, 56
Number of participants with abnormal changes in vital signs - Body temperature
Time frame: Day 0 (screening); 10 min before, 20 min and 2 hours after vaccination; days 3, 7, 28, 56
Number of participants with clinically significant abnormalities - Complete blood count (CBC)
Time frame: Days 0 (screening), 3
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
Time frame: Days 0 (screening), 3
Number of participants with clinically significant abnormalities - Urinalysis
Time frame: Days 0 (screening), 3
Number of participants with abnormal changes of total IgE
Time frame: Days 0 (screening), 3, 56

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 22 Jul 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.

Ellina Ruzanova, PhD study director

St. Petersburg Research Institute of Vaccines and Sera

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 22 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 seroconversion level (time frame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination). 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 NCT05470582.

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 22 Jul 2022.