InfluenzaPhase 1NCT05126979
The Objectives of This Study Are Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
A Phase 1 study testing Inactivated Split Influenza Vaccine in people with Influenza, run by St. Petersburg Research Institute of Vaccines and Sera at 1 site in Russia.
Trial summary
Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Inactivated Split Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteRussia
- Study dates
- 9 Mar 2016to 13 May 2016
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent of the volunteers to participate in the clinical study;
- Healthy volunteers (men and women) aged 18-60 years;
- Volunteers with a titer of antibodies to A(H1N1), A(H3N2) and B influenza viruses less than 1:40 in a HI test
- Volunteers able to fulfill requirements of the protocol (i.e. fill out the patient's diary, come to follow-up visits);
- Female participants were obliged to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception for women of reproductive age)
Who cannot join
- Allergic reactions to chicken protein or any previous influenza vaccination;
- Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history;
- Volunteers who received immunoglobulin or blood products within the last three months before the study;
- Guillain-Barre syndrome (acute polyneuropathy) in the medical history;
- Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the study;
- Any confirmed or suspected immunosuppressive or immunodeficiency condition;
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- Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests at Visit 1;
- Severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination;
- Volunteers who are (or were) patients of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary
- acute infectious and/or non-infectious diseases at the time of inclusion in the study;
- Exacerbation of chronic diseases;
- Alcohol abuse and/or use of drugs in the past history;
- Pregnancy and lactation;
- Participation in another clinical study within the last 3 months
Trial locations and contacts
1 site in 1 country.
Russia1 site
Perm State Medical University named after academician E.A. Wagner
Perm
About this study
Official title: Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
Read the detailed description
All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.
- Conditions
- Influenza
- Being tested
- Inactivated Split Influenza Vaccine, Placebo
- 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.
Inactivated Split Influenza VaccineBiological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Flu-M (without a preservative) | Experimental | 15 volunteers were treated with the Flu-M inactivated split influenza vaccine without a preservative Receives: Biological: Inactivated Split Influenza Vaccine |
| Flu-M (with a preservative) | Experimental | 15 volunteers were treated with the Flu-M inactivated split influenza vaccine with a preservative Receives: Biological: Inactivated Split Influenza Vaccine |
| Placebo | Placebo comparator | 15 volunteers were treated with a placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of reported local reactions and their relationship with the vaccination
Measured: days 1-7
Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days)
Measured: days 1-7
Severity of local reactions reported by participants of the study and their relationship with the vaccination
Measured: days 8-20
Severity of system reactions reported by participants of the study and their relationship with the vaccination
Measured: days 8-20
The measurement physical data at each visit of the trial site by the volunteer
Measured: days 1-20
Secondary outcomes (4)
The immunogenicity assessment of the vaccine was carried out by the seroconversion factor
Measured: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by Geometric mean titer
Measured: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by seroprotection levels
Measured: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by seroconversion
Measured: Measurements will be taken at screening, then up to 21 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 posted19 Nov 2021
- Study start9 Mar 2016
- Primary completion25 Apr 2016
- Study completion13 May 2016
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 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
- NCT05126979
- Sponsor's protocol ID
- FMV-VGIR-1-001/15
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 6 Jan 2022
- Results posted
- 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
- Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
- ClinicalTrials.gov ID
- NCT05126979
- Acronym / sponsor ID
- FMV-VGIR-1-001/15
- Conditions
- Influenza
- Keywords
- influenza, flu, vaccine, Flu-M
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and SeraOther government
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 25 Apr 2016 (actual)
- Study completion
- 13 May 2016 (actual)
- First posted
- 19 Nov 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.
Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
Detailed description
All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flu-M (without a preservative) | Experimental | Biological: Inactivated Split Influenza Vaccine15 volunteers were treated with the Flu-M inactivated split influenza vaccine without a preservative |
| Flu-M (with a preservative) | Experimental | Biological: Inactivated Split Influenza Vaccine15 volunteers were treated with the Flu-M inactivated split influenza vaccine with a preservative |
| Placebo | Placebo comparator | Biological: Placebo15 volunteers were treated with a placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent of the volunteers to participate in the clinical study;
- Healthy volunteers (men and women) aged 18-60 years;
- Volunteers with a titer of antibodies to A(H1N1), A(H3N2) and B influenza viruses less than 1:40 in a HI test
- Volunteers able to fulfill requirements of the protocol (i.e. fill out the patient's diary, come to follow-up visits);
- Female participants were obliged to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception for women of reproductive age)
Key exclusion criteria (14 listed)
- Allergic reactions to chicken protein or any previous influenza vaccination;
- Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history;
- Volunteers who received immunoglobulin or blood products within the last three months before the study;
- Guillain-Barre syndrome (acute polyneuropathy) in the medical history;
- Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the study;
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 |
|---|---|---|
| Inactivated Split Influenza Vaccine | Biological | Flu-M (with a preservative), Flu-M (without a preservative) |
| Placebo | Biological | Placebo |
Primary outcome
Severity of reported local reactions and their relationship with the vaccination
Time frame: days 1-7
Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days)
Time frame: days 1-7
Severity of local reactions reported by participants of the study and their relationship with the vaccination
Time frame: days 8-20
Severity of system reactions reported by participants of the study and their relationship with the vaccination
Time frame: days 8-20
The measurement physical data at each visit of the trial site by the volunteer
Time frame: days 1-20
4 secondary outcomes
The immunogenicity assessment of the vaccine was carried out by the seroconversion factor
Time frame: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by Geometric mean titer
Time frame: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by seroprotection levels
Time frame: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by seroconversion
Time frame: Measurements will be taken at screening, then up to 21 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 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inactivated Split Influenza Vaccine in people with Influenza, run by St. Petersburg Research Institute of Vaccines and Sera at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 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 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Severity of reported local reactions and their relationship with the vaccination (time frame: days 1-7). The study lists 5 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 6 Jan 2022.