InfluenzaPhase 3NCT05317767
The Objectives of This Study Are Comparative Assessment of the Tolerability, Safety and Immunogenicity of the Flu-M Vaccine vs. the Ultrix® Vaccine by Single Vaccination of Children Aged 6 to 17 Years.
A Phase 3 study testing Flu-M [Inactivated split influenza vaccine] and Inactivated Split Influenza Vaccine in people with Influenza, run by St. Petersburg Research Institute of Vaccines and Sera at 2 sites in Russia.
Trial summary
Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flu-M [Inactivated split influenza vaccine] and 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
- 600 participants
- Where
- 2 sitesRussia
- Study dates
- 10 Feb 2020to 14 Sep 2020
- 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 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For volunteers aged 12 to 17 years:
- Healthy children1 of both sexes aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days);
- The written and dated informed consent of the volunteer (children aged 14-17 years) one of the parents 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 mensis in the medical history shall have a negative pregnancy test result.
- For volunteers aged 6 to 11 years:
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- Healthy children of both sexes aged 6 to 11 years (6 years 0 months 0 days - 11 years 11 months 30 days);
- The written and dated informed consent of one of the parents for participation in the trial;
- For all volunteers:
- Ability of a volunteer / 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 or previous influenza vaccination during 6 months before the trial;
- 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) 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;
- Encephalopathy that developed within 7 days of a previous vaccine administration;
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- History of hematopoietic system, cancer;
- 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 (for more than 14 days) of any immunomodulating drugs (immunoregulating peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon)) less than 3 months prior to the commencement 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;
- History of progressive neurological pathology, convulsive syndrome, afebrile convulsions;
- Acute infectious or non-infectious diseases less than 2 weeks before vaccination;
- Participation in another clinical trial less than 3 months before the start of the trial;
- Smoking (for children of older age group);
- Drug or alcohol abuse in the medical history (for children of older age group);
- Serious concurrent illnesses or pathological conditions not listed above which, in the opinion of the investigator, could complicate the assessment of the results of the trial including pathological deviations from age norms and norms of laboratory blood and urine parameters, which are clinically significant in the opinion of the investigator, or which may be a counter-indicative to participation in the trial in the opinion of the investigator;
- History of mental illness of the volunteer's parents
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Perm State Medical University named after Academician E. A. Wagner
Perm
LLC "Meditsinskie Tehnologii"
Saint Petersburg
About this study
Official title: Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of Flu-M [Inactivated Split Influenza Vaccine], vs. the Ultrix® Vaccine in Children Aged 6 to 17 Years (Inclusive)
Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years.
Read the detailed description
At Stage I of the trial, it is planned to screen not more than 350 children aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days), of which it is planned to include and randomize 300 children meeting the inclusion and non-inclusion criteria.
Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Ultrix® vaccine in the first 7 days after the vaccination of volunteers, during Phase I, an "Opinion on Tolerability and Safety Assessment for the Flu-M Vaccine vs. the Ultrix® Vaccine Involving Children Aged 12-17 Years (12 Years 0 Months 0 Days - 17 Years 11 Months 30 Days) will be prepared/
During Phase II , the trial for Phase I volunteers will continue in full in accordance with the Clinical Trial Regulations.
During the trial, not more than 350 children aged between 6 - 11 years (6 years 0 months - 0 days - 11 years 11 months 30 days) will be further screened, of which it is planned to include and randomize 300 children meeting the inclusion criteria and not falling under the non-inclusion criteria.
- Conditions
- Influenza
- Being tested
- Flu-M [Inactivated split influenza vaccine], Inactivated Split Influenza Vaccine
- Keywords
- influenza, flu, vaccine, Flu-M, FluM, Ultrix, 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]Biological
solution for intramuscular injection, 0.5 ml
Inactivated Split Influenza VaccineBiological
solution for intramuscular injection, 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| Flu-M | Experimental | 300 children that will be vaccinated with a single dose of the Flu-M vaccine intramuscularly at a dose of 0.5 mL (150 children aged 12 to 17 years, 150 children aged 6 to 11 years) Receives: Biological: Flu-M [Inactivated split influenza vaccine] |
| Ultrix | Active comparator | 300 children that will be vaccinated with a single dose of the Ultrix® vaccine intramuscularly at a dose of 0.5 mL (150 children aged 12 to 17 years, 150 children aged 6 to 11 years) Receives: Biological: Inactivated Split Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Geometric mean antibodies titer (GMT) at 28 days
Measured: Days 0-28
Change from Baseline Seroconversion rate at 28 days
An increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise.
Seroconversion level ≥ 40%.
Measured: Days 0-28
Change from Baseline Seroprotection rate at 28 days
The percentage of subjects with a generated protective influenza haemagglutinin antibody titer (HA titer) (at least 1:40) vs. the baseline level.
Seroprotection level ≥ 70%.
Measured: Days 0-28
Change from Baseline Seroconversion factor at 28 days
The percentage of subjects who have a prevaccination titer of HA titer <1:10 and a post-vaccination HA titer >1:40 OR a prevaccination HA titer > 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline.
Seroconversion factor ≥ 2.5.
Measured: Days 0-28
Secondary outcomes (3)
Immediate adverse events
Allergic reactions that revaccination and are reported either by a volunteer / volunteer's parents to the clinical investigator
Measured: During 2 hours after vaccination
Adverse events
Local or systemic reactions that are reported either by a clinical investigator or by a volunteer / vaccinated volunteer's parents by phone
Measured: During 7 days after vaccination
Incidence of severe adverse events during the trial
Measured: Measurements will be taken then up to 28 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start10 Feb 2020
- Primary completion5 Jul 2020
- Study completion14 Sep 2020
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 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
- NCT05317767
- Sponsor's protocol ID
- FLU-III-D-07/19
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2021
- Last updated
- 8 Apr 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of Flu-M [Inactivated Split Influenza Vaccine], vs. the Ultrix® Vaccine in Children Aged 6 to 17 Years (Inclusive)
- ClinicalTrials.gov ID
- NCT05317767
- Acronym / sponsor ID
- FLU-III-D-07/19
- Conditions
- Influenza
- Keywords
- influenza, flu, vaccine, Flu-M, FluM, Ultrix, SPbSRIVS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and SeraOther government
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 5 Jul 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 8 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 vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years.
Detailed description
At Stage I of the trial, it is planned to screen not more than 350 children aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days), of which it is planned to include and randomize 300 children meeting the inclusion and non-inclusion criteria.
Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Ultrix® vaccine in the first 7 days after the vaccination of volunteers, during Phase I, an "Opinion on Tolerability and Safety Assessment for the Flu-M Vaccine vs. the Ultrix® Vaccine Involving Children Aged 12-17 Years (12 Years 0 Months 0 Days - 17 Years 11 Months 30 Days) will be prepared/
During Phase II , the trial for Phase I volunteers will continue in full in accordance with the Clinical Trial Regulations.
During the trial, not more than 350 children aged between 6 - 11 years (6 years 0 months - 0 days - 11 years 11 months 30 days) will be further screened, of which it is planned to include and randomize 300 children meeting the inclusion criteria and not falling under the non-inclusion criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flu-M | Experimental | Biological: Flu-M [Inactivated split influenza vaccine]300 children that will be vaccinated with a single dose of the Flu-M vaccine intramuscularly at a dose of 0.5 mL (150 children aged 12 to 17 years, 150 children aged 6 to 11 years) |
| Ultrix | Active comparator | Biological: Inactivated Split Influenza Vaccine300 children that will be vaccinated with a single dose of the Ultrix® vaccine intramuscularly at a dose of 0.5 mL (150 children aged 12 to 17 years, 150 children aged 6 to 11 years) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Healthy children1 of both sexes aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days);
- The written and dated informed consent of the volunteer (children aged 14-17 years) one of the parents 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 mensis in the medical history shall have a negative pregnancy test result.
- Healthy children of both sexes aged 6 to 11 years (6 years 0 months 0 days - 11 years 11 months 30 days);
Key exclusion criteria (19 listed)
- History of influenza or previous influenza vaccination during 6 months before the trial;
- 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) 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 [Inactivated split influenza vaccine]solution for intramuscular injection, 0.5 ml | Biological | Flu-M |
| Inactivated Split Influenza Vaccinesolution for intramuscular injection, 0.5 ml | Biological | Ultrix |
Primary outcome
Change from Baseline Geometric mean antibodies titer (GMT) at 28 days
Time frame: Days 0-28
Change from Baseline Seroconversion rate at 28 days
Time frame: Days 0-28
An increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise. Seroconversion level ≥ 40%.
Change from Baseline Seroprotection rate at 28 days
Time frame: Days 0-28
The percentage of subjects with a generated protective influenza haemagglutinin antibody titer (HA titer) (at least 1:40) vs. the baseline level. Seroprotection level ≥ 70%.
Change from Baseline Seroconversion factor at 28 days
Time frame: Days 0-28
The percentage of subjects who have a prevaccination titer of HA titer <1:10 and a post-vaccination HA titer >1:40 OR a prevaccination HA titer > 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline. Seroconversion factor ≥ 2.5.
3 secondary outcomes
Immediate adverse events
Time frame: During 2 hours after vaccination
Adverse events
Time frame: During 7 days after vaccination
Incidence of severe adverse events during the trial
Time frame: Measurements will be taken then up to 28 days post-vaccination
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 Apr 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.
2 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 Flu-M [Inactivated split influenza vaccine] and Inactivated Split Influenza Vaccine in people with Influenza, run by St. Petersburg Research Institute of Vaccines and Sera at 2 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 10 inclusion and 19 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 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 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 Geometric mean antibodies titer (GMT) at 28 days (time frame: Days 0-28). The study lists 4 primary outcomes in all. 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 Apr 2022.