InfluenzaPhase 3NCT05739474
Tolerability, Safety and Immunogenicity Trial of the Flu-M Tetra Vaccine in Children
A Phase 3 study testing Influenza vaccine [inactivated] in people with Influenza and Influenza, Human, run by St. Petersburg Research Institute of Vaccines and Sera at 7 sites in Russia.
Trial summary
The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive. Read more about this study
- Who is it for?
- Ages 6 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza, Human, Influenza Viral Infections
- What is being tested?
- Influenza vaccine [inactivated]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 948 participants
- Where
- 7 sitesRussia
- Study dates
- 19 Jan 2022to 30 Dec 2023
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For volunteers aged 10 to 17 years:
- Healthy children of both sexes aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days);
- The availability of written and dated informed consent of the volunteer (children aged 14 to 17 years) and their parent / legally acceptable representative for participation in the trial;
- If the volunteer has sexual relations, effective contraception methods must be used during the 30 days preceding vaccination and consent must be obtained to continue using these contraceptive methods during the trial and for two months after vaccination;
- The girls with menses in the medical history shall have a negative pregnancy test result.
- For volunteers aged 3 to 9 years:
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- Healthy children of both sexes aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days);
- The availability of written and dated informed consent of a parent / legally acceptable representative 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 availability of written and dated informed consent of a parent / legally acceptable representative for participation in the trial.
- The trial subject of the was born full-term, with the Apgar score of 7-10 points.
- For all volunteers:
- The ability of a volunteer's parents / legally acceptable representatives to perform the requirements of the Protocol (i.e., fill out the Patient Diary, attend visits together 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;
- Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine
- Positive result of the SARS-CoV-2 test;
- 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 / legally acceptable representatives;
- 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 / legally acceptable representative 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
7 sites in 1 country.
7 sites in 1 country
Russia7 sites, 5 recruiting
- Recruiting
State Autonomous Health Care Institution "Engels City Clinical Hospital No1"
Engel's
Oksana Nesterenko, PhD
- Recruiting
Llc "Olla-Med"
Moscow
Maria Plekhanova, MD
- Not yet recruiting
LLC "Professorskaya Clinica"
Perm
Svetlana Teplykh, PhD
- Active, not recruiting
State Budgetary Healthcare Institution of the Perm Territory "City Children's Clinical Clinic No. 5"
Perm
- Recruiting
LLC PiterClinica
Saint Petersburg
Tatiana Pak, PhD
- Recruiting
LLC "DNA Research Center"
Saratov
Inna Gamova, PhD
- Active, not recruiting
State Autonomous Health Care Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11"
Yekaterinburg
About this study
Official title: Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Tetra Vaccine in Children Between 6 Months and 17 Years Old
The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive.
Read the detailed description
The trial will be conducted in three stages.
- Stage I Participants - children aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days), will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly.
Once reviewed by the Sponsor, the report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II trial.
- Stage II Participants - children aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days), will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly (double dose for volunteers who have not been vaccinated before).
Once reviewed by the Sponsor, the report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage III trial.
- Stage III Participants - children aged 6 to 35 months (6 months 0 days - 35 months 30 days), will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly.
- Being tested
- Influenza vaccine [inactivated]
- Keywords
- Influenza, Flu, Vaccine, Vaccination, SPbSRIVS, 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.
Influenza vaccine [inactivated]Biological
Also called Flu-M Tetra Inactivated Split Quadrivalent Influenza Vaccine
solution for intramuscular injection, 1 dose (0.5 mL)
Influenza vaccine [inactivated]Biological
Also called VaxigripTetra (inactivated split influenza vaccine)
suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL)
| Study group | Role | What they receive |
|---|---|---|
| Flu-M Tetra vaccine, children aged 10 to 17 years old | Experimental | Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly Receives: Biological: Influenza vaccine [inactivated] |
| VaxigripTetra vaccine, children aged 10 to 17 years old | Active comparator | Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly Receives: Biological: Influenza vaccine [inactivated] |
| Flu-M Tetra vaccine, children aged 3 to 9 years old | Experimental | Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before Receives: Biological: Influenza vaccine [inactivated] |
| VaxigripTetra vaccine, children aged 3 to 9 years old | Active comparator | Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before Receives: Biological: Influenza vaccine [inactivated] |
| Flu-M Tetra vaccine, children aged 6 to 35 months old | Experimental | Сhildren will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine intramuscularly Receives: Biological: Influenza vaccine [inactivated] |
| VaxigripTetra vaccine, children aged 6 to 35 months old | Active comparator | Сhildren will be vaccinated twice 0.25 mL dose of the VaxigripTetra vaccine intramuscularly Receives: Biological: Influenza vaccine [inactivated] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B)
Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated participants in haemagglutination inhibition assay
Measured: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Secondary outcomes (19)
Change from Baseline Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)
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: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Change from Baseline Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)
Seroprotection rate refers to the percentage of subjects with a generated protective HA titer (at least 1:40) vs. the baseline level
Measured: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Change from Baseline Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)
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: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Incidence of immediate adverse events (allergic reactions)
Measured: 2 hours after vaccination
Incidence of local adverse events
Measured: 7 days after vaccination
Incidence of systemic adverse events
Measured: 7 days after vaccination
Incidence of other adverse reactions
Measured: Days 8 to 28 after vaccination
Incidence of severe adverse events
Measured: Days 1 to 28+3 (for participants with 1 vaccination), Day 1 to 56±3 (for participants with vaccination and revaccination)
Withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products
Measured: Days 1 to 28+3 (for participants with 1 vaccination), Day 1 to 56±3 (for participants with vaccination and revaccination)
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.
It is necessary to conduct an examination of the following organs and systems: skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, heart/cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system
Measured: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Number of participants with abnormal changes in vital signs - Blood pressure (BP)
BP is assessed in children aged 36 months and older. BP measurements include the systolic and diastolic blood pressure.
Measured: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
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 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
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 conducted during one minute.
Measured: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Number of participants with abnormal changes in vital signs - Body temperature
The body temperature is measured with a digital thermometer.
Measured: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Number of participants with clinically significant abnormalities - Complete blood count (CBC)
Hemoglobin, Hematocrit, Erythrocytes, Leukocytes, Leukocytic Formula, Platelets, Erythrocyte Sedimentation Rate (ESR)
Measured: Days 1, 3
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
ALT, AST, Alkaline Phosphatase, Total Bilirubin, Total Protein, Urea, Glucose
Measured: Days 1, 3
Number of participants with clinically significant abnormalities - Urinalysis
pH, Color, Relative Density/Specific Gravity, Protein, Glucose, Red Blood Cells, White Blood Cells
Measured: Days 1, 3
Number of participants with abnormal changes of total IgE
Measured: Days 1, 3
Number of participants with abnormal neurological examinations
Measured: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start19 Jan 2022
- Primary completion30 Jun 2023
- Study completion30 Dec 2023 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 948 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and Sera
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ellina Ruzanova, PhD, Study director, St. Petersburg Research Institute of Vaccines and Sera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739474
- Sponsor's protocol ID
- FLМ-ТЕ-05-2021
- Status last verified
- Aug 2023
- First submitted
- 13 Feb 2023
- Last updated
- 30 Aug 2023
- 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 30 Aug 2023. 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 Tetra Vaccine in Children Between 6 Months and 17 Years Old
- ClinicalTrials.gov ID
- NCT05739474
- Acronym / sponsor ID
- FLМ-ТЕ-05-2021
- Keywords
- Influenza, Flu, Vaccine, Vaccination, SPbSRIVS, Flu-M Tetra
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 948 participants (estimated)
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and SeraOther government
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Feb 2023 (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.
The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive.
Detailed description
The trial will be conducted in three stages.
- Stage I Participants - children aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days), will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly.
Once reviewed by the Sponsor, the report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II trial.
- Stage II Participants - children aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days), will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly (double dose for volunteers who have not been vaccinated before).
Once reviewed by the Sponsor, the report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage III trial.
- Stage III Participants - children aged 6 to 35 months (6 months 0 days - 35 months 30 days), will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Flu-M Tetra vaccine, children aged 10 to 17 years old | Experimental | Biological: Influenza vaccine [inactivated]Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly |
| VaxigripTetra vaccine, children aged 10 to 17 years old | Active comparator | Biological: Influenza vaccine [inactivated]Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly |
| Flu-M Tetra vaccine, children aged 3 to 9 years old | Experimental | Biological: Influenza vaccine [inactivated]Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before |
| VaxigripTetra vaccine, children aged 3 to 9 years old | Active comparator | Biological: Influenza vaccine [inactivated]Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before |
| Flu-M Tetra vaccine, children aged 6 to 35 months old | Experimental | Biological: Influenza vaccine [inactivated]Сhildren will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine intramuscularly |
| VaxigripTetra vaccine, children aged 6 to 35 months old | Active comparator | Biological: Influenza vaccine [inactivated]Сhildren will be vaccinated twice 0.25 mL dose of the VaxigripTetra vaccine intramuscularly |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Healthy children of both sexes aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days);
- The availability of written and dated informed consent of the volunteer (children aged 14 to 17 years) and their parent / legally acceptable representative for participation in the trial;
- If the volunteer has sexual relations, effective contraception methods must be used during the 30 days preceding vaccination and consent must be obtained to continue using these contraceptive methods during the trial and for two months after vaccination;
- The girls with menses in the medical history shall have a negative pregnancy test result.
- Healthy children of both sexes aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days);
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;
- Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine
- Positive result of the SARS-CoV-2 test;
- 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 |
|---|---|---|
| Influenza vaccine [inactivated]Also: Flu-M Tetra Inactivated Split Quadrivalent Influenza Vaccinesolution for intramuscular injection, 1 dose (0.5 mL) | Biological | Flu-M Tetra vaccine, children aged 10 to 17 years old, Flu-M Tetra vaccine, children aged 3 to 9 years old, Flu-M Tetra vaccine, children aged 6 to 35 months old |
| Influenza vaccine [inactivated]Also: VaxigripTetra (inactivated split influenza vaccine)suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL) | Biological | VaxigripTetra vaccine, children aged 10 to 17 years old, VaxigripTetra vaccine, children aged 3 to 9 years old, VaxigripTetra vaccine, children aged 6 to 35 months old |
Primary outcome
Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B)
Time frame: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated participants in haemagglutination inhibition assay
19 secondary outcomes
Change from Baseline Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)
Time frame: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Change from Baseline Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)
Time frame: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Change from Baseline Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)
Time frame: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Incidence of immediate adverse events (allergic reactions)
Time frame: 2 hours after vaccination
Incidence of local adverse events
Time frame: 7 days after vaccination
Incidence of systemic adverse events
Time frame: 7 days after vaccination
Incidence of other adverse reactions
Time frame: Days 8 to 28 after vaccination
Incidence of severe adverse events
Time frame: Days 1 to 28+3 (for participants with 1 vaccination), Day 1 to 56±3 (for participants with vaccination and revaccination)
Withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products
Time frame: Days 1 to 28+3 (for participants with 1 vaccination), Day 1 to 56±3 (for participants with vaccination and revaccination)
Number of participants with abnormal physical examination findings
Time frame: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Number of participants with abnormal changes in vital signs - Blood pressure (BP)
Time frame: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Number of participants with abnormal changes in vital signs - Heart rate (HR)
Time frame: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
Time frame: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Number of participants with abnormal changes in vital signs - Body temperature
Time frame: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Number of participants with clinically significant abnormalities - Complete blood count (CBC)
Time frame: Days 1, 3
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
Time frame: Days 1, 3
Number of participants with clinically significant abnormalities - Urinalysis
Time frame: Days 1, 3
Number of participants with abnormal changes of total IgE
Time frame: Days 1, 3
Number of participants with abnormal neurological examinations
Time frame: Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Influenza vaccine [inactivated] in people with Influenza and Influenza, Human, run by St. Petersburg Research Institute of Vaccines and Sera at 7 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 14 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellina Ruzanova, PhD ((812) 660-06-39, e.a.ruzanova@niivs.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B) (time frame: Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)). 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 30 Aug 2023.