InfluenzaPhase 3NCT05089123
The Objectives of This Study Are Study the Immunogenicity and Safety of the Flu-M [Inactivated Split Influenza Vaccine], vs. the Ultrix® Inactivated Split Influenza Vaccine, in Volunteers Who Are Over 60 Years Old
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
This trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the IIIb-IV phase which was carried out in parallel groups of volunteers over the age of 60 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 [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
- 320 participants
- Where
- 2 sitesRussia
- Study dates
- 3 Mar 2020to 24 Aug 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of signed informed consent to participate in the trial.
- Volunteers (both male and female) over the age of 60 who could meet the Protocol requirements.
- Negative pregnancy test obtained from female volunteers with preserved childbearing potential.
- Consent to use adequate contraception methods (contraception methods with degree of reliability of more than 90%: a nonhormonal intrauterine device; a spermicide condom; a spermicide cervical cap; spermicide diaphragms) or total sexual abstinence during the clinical trial (until Visit 5 (day 28(+2)).
Who cannot join
- Allergic reactions to chicken protein or any previous influenza vaccination.
- Anamnestic data on the episodes of severe allergic reactions and/or diseases (anaphylaxis, Quincke's edema, polymorphic exudative erythema, serum disease etc.)
- Acute reaction (temperature above 38.5оС, edema and hyperemia over 5 cm in diameter at the injection site) or complications caused by previous administration of the drug.
- Previous vaccination 6 months before the start of the trial.
- History of leucosis, blood cancer, malignant oncological diseases.
- Guillain-Barré syndrome (acute polyneuropathy) in the medical history.
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- Positive screening for HIV infection, B and C hepatitis, syphilis.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition;
- Administration of immunoglobulin or blood products within the last three months before the study.
- Long-term use (more than 14 days) of immunosuppressants (including systemic corticosteroids, cytotoxic, radioactive preparations) or other immunomodulatory drugs for six months before the trial.
- Chronic diseases at the decompensation stage or in debilitating form, which can make it dangerous for the volunteer to take part in the trial.
- Progressive neurological disorders, dementia.
- Blood disorders which serve as a contradiction for intramuscular injection.
- History of alcohol or drug addiction.
- Pregnancy, breastfeeding in women with preserved reproductive performance.
- Current participation in another clinical trial or within the previous 3 months before the screening.
- Mental, physical and other problems which do not allow for appropriate assessment of own behavior and following the requirements set out in the trial protocol.
- Any other conditions which in the reasonable opinion of the clinical investigator complicate the participation of the volunteer in the trial
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
LLC "Meditsinskie Tehnologii"
Saint Petersburg
LLC "Strategicheskie Meditsinskie Sistemi"
Saint Petersburg
About this study
Official title: Prospective, Multicenter, Double-blind, Randomized, Comparative Immunogenicity and Safety Trial of Flu-M [Inactivated Split Influenza Vaccine], Solution for Intramuscular Injection, 0.5 ml (FSUE SPbSRIVS FMBA), vs. Ultrix®, Solution for Intramuscular Injection, 0.5 ml (FORT LLC) in Volunteers Aged Over 60 Years
This trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the IIIb-IV phase which was carried out in parallel groups of volunteers over the age of 60
Read the detailed description
The volunteers will include in the trial will divide into two groups:
Group 1: volunteers who will receive one dose of Flu-M, solution for intramuscular injection, 0.5 mL, intramuscularly.
Group 2: volunteers who will receive one dose of Ultrix®, solution for intramuscular administration, 0.5 mL, intramuscularly.
The trial include the following periods and visits:
- Screening period (up to 7 days):
- Visit 0 (day -7...-1).
- Vaccination period (up to 1 day):
- Visit 1 (day 1, randomization, blood collection for serological examination, vaccination).
- Follow-up period (up to 28(+2) days):
- Visit 2 (day 3, organization of trials to assess safety);
- Visit 3 (day 7(+1), organization of trials to assess safety);
- Visit 4 (day 21(+2), organization of trials to assess safety, blood collection for serological study);
- Visit 5 (day 28(+2), organization of trials to assess safety, trial completion);
- Conditions
- Influenza
- Being tested
- Flu-M [Inactivated split influenza vaccine], Inactivated Split Influenza Vaccine
- Keywords
- influenza, flu, vaccine, Flu-M
- 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 | 160 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative Receives: Biological: Flu-M [Inactivated split influenza vaccine] |
| Ultrix | Active comparator | 160 volunteers were vaccinated with the Ultrix (Inactivated split influenza vaccine) Receives: Biological: Inactivated Split Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity assessment
Seroconversion rate defined as the percentage of subjects who have a pre-vaccination titer of influenza haemagglutinin antibody titer (HA titer) < 1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline for each strain (A/H1N1, A/H3N2 and B)
Measured: 21 days
Secondary outcomes (5)
The percentage of subjects with protective titer of antibodies ≥ 1:40 on the 21(+2) day after the vaccination for each strain (A/H1N1, A/H3N2 and B).
Measured: 21 days
Increasing of geometric mean titer on the 21(+2) day against the value observed before the use of vaccine for each strain (A/H1N1, A/H3N2 and B)
Measured: 21 days
The percentage of volunteers with a pre-vaccination HA titer <1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in a post-vaccination HA titer vs. the baseline should be > 30%
Measured: 21 days
Increasing of geometric mean titer in > 2.0 times
Measured: 21 days
The percentage with protective antibody titer ≥ 1:40
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start3 Mar 2020
- Primary completion28 May 2020
- Study completion24 Aug 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 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
- NCT05089123
- Sponsor's protocol ID
- FM-2019-02
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 6 Jan 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 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Double-blind, Randomized, Comparative Immunogenicity and Safety Trial of Flu-M [Inactivated Split Influenza Vaccine], Solution for Intramuscular Injection, 0.5 ml (FSUE SPbSRIVS FMBA), vs. Ultrix®, Solution for Intramuscular Injection, 0.5 ml (FORT LLC) in Volunteers Aged Over 60 Years
- ClinicalTrials.gov ID
- NCT05089123
- Acronym / sponsor ID
- FM-2019-02
- Conditions
- Influenza
- Keywords
- influenza, flu, vaccine, Flu-M
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and SeraOther government
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 22 Oct 2021 (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.
This trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the IIIb-IV phase which was carried out in parallel groups of volunteers over the age of 60
Detailed description
The volunteers will include in the trial will divide into two groups:
Group 1: volunteers who will receive one dose of Flu-M, solution for intramuscular injection, 0.5 mL, intramuscularly.
Group 2: volunteers who will receive one dose of Ultrix®, solution for intramuscular administration, 0.5 mL, intramuscularly.
The trial include the following periods and visits:
- Screening period (up to 7 days):
- Visit 0 (day -7...-1).
- Vaccination period (up to 1 day):
- Visit 1 (day 1, randomization, blood collection for serological examination, vaccination).
- Follow-up period (up to 28(+2) days):
- Visit 2 (day 3, organization of trials to assess safety);
- Visit 3 (day 7(+1), organization of trials to assess safety);
- Visit 4 (day 21(+2), organization of trials to assess safety, blood collection for serological study);
- Visit 5 (day 28(+2), organization of trials to assess safety, trial completion);
Study design
- Primary purpose
- Prevention
- 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]160 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative |
| Ultrix | Active comparator | Biological: Inactivated Split Influenza Vaccine160 volunteers were vaccinated with the Ultrix (Inactivated split influenza vaccine) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of signed informed consent to participate in the trial.
- Volunteers (both male and female) over the age of 60 who could meet the Protocol requirements.
- Negative pregnancy test obtained from female volunteers with preserved childbearing potential.
- Consent to use adequate contraception methods (contraception methods with degree of reliability of more than 90%: a nonhormonal intrauterine device; a spermicide condom; a spermicide cervical cap; spermicide diaphragms) or total sexual abstinence during the clinical trial (until Visit 5 (day 28(+2)).
Key exclusion criteria (18 listed)
- Allergic reactions to chicken protein or any previous influenza vaccination.
- Anamnestic data on the episodes of severe allergic reactions and/or diseases (anaphylaxis, Quincke's edema, polymorphic exudative erythema, serum disease etc.)
- Acute reaction (temperature above 38.5оС, edema and hyperemia over 5 cm in diameter at the injection site) or complications caused by previous administration of the drug.
- Previous vaccination 6 months before the start of the trial.
- History of leucosis, blood cancer, malignant oncological diseases.
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
Immunogenicity assessment
Time frame: 21 days
Seroconversion rate defined as the percentage of subjects who have a pre-vaccination titer of influenza haemagglutinin antibody titer (HA titer) < 1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline for each strain (A/H1N1, A/H3N2 and B)
5 secondary outcomes
The percentage of subjects with protective titer of antibodies ≥ 1:40 on the 21(+2) day after the vaccination for each strain (A/H1N1, A/H3N2 and B).
Time frame: 21 days
Increasing of geometric mean titer on the 21(+2) day against the value observed before the use of vaccine for each strain (A/H1N1, A/H3N2 and B)
Time frame: 21 days
The percentage of volunteers with a pre-vaccination HA titer <1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in a post-vaccination HA titer vs. the baseline should be > 30%
Time frame: 21 days
Increasing of geometric mean titer in > 2.0 times
Time frame: 21 days
The percentage with protective antibody titer ≥ 1:40
Time frame: 21 days
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 6 Jan 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 4 inclusion and 18 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 6 Jan 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?
Immunogenicity assessment (time frame: 21 days). 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 6 Jan 2022.