InfluenzaPhase 1NCT05152017
The Objectives of This Study Are Study the Safety, Reactogenicity and Obtain Preliminary Data on the Immunogenicity of Flu-M Quadro, 4-valent Inactivated Split Influenza Vaccine, in Healthy Volunteers
A Phase 1 study testing Flu-M Quadro [inactivated split influenza vaccine] with preservative and Flu-M Quadro [inactivated split influenza vaccine] without preservative in people with Influenza, run by St. Petersburg Research Institute of Vaccines and Sera at 1 site in Russia.
Trial summary
The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers 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?
- Flu-M Quadro [inactivated split influenza vaccine] with preservative and Flu-M Quadro [inactivated split influenza vaccine] without preservative
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteRussia
- Study dates
- 16 Nov 2019to 24 Jan 2020
- 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
- Voluntarily and personally signed form of informed consent for participation in the trial, before any trial procedure is carried out.
- Verified diagnosis "healthy", at that the clinical investigator shall confirm the absence of pathology on the part of the main organs and systems, previously conducted standard clinical, laboratory and instrumental studies did not reveal any diseases.
- Age between 18 and 60 years old, inclusively.
- Ability to attend all planned visits and all scheduled procedures and studies.
- Willingness of the volunteers to complete Self-Observation Diaries in between their visits to a clinical center.
- Previous vaccination against seasonal influenza at least 9 months prior to inclusion in this trial.
- Consent of the volunteers to use effective contraception methods contraception throughout the trial, including the term of observation for possible post-vaccination reactions
Who cannot join
- Known hypersensitivity to any of the components of the tested products, as well as to chicken meat or chicken/quail eggs.
- Allergic reaction to any previous influenza vaccination.
- Adverse reaction of severe degree of manifestation or serious adverse reaction to previous influenza vaccine administration.
- Signs of any disease at the time of inclusion in the trial or if less than 4 weeks have expired after recovery.
- Any acute respiratory disease less than 3 months before inclusion in the trial.
- Guillain-Barré syndrome (acute polyneuropathy) in the medical history.
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- History of leukemia, tuberculosis, cancer, autoimmune diseases.
- Volunteers who received immunoglobulin or blood products within the last three months before the trial.
- Long-term use (exceeding 14 days) of immunosuppressants, systemic corticosteroids or immunomodulatory agents within 6 months before the trial
- Vaccination with any vaccine within one month before the vaccination.
- Acute infectious or non-communicable diseases, acute exacerbation of a chronic diseases within 4 weeks before the screening.
- Scheduled use of vaccines not provided by the tested protocol within 30 days (inclusively) after the vaccination.
- Pregnant and breastfeeding women.
- Positive blood test results for HIV, syphilis, hepatitis B/C.
- Participation in another clinical trial within 30 days before the screening visit or in parallel with the current trial.
- History of alcohol addiction, drug addiction or abuse of pharmaceutical products.
- Inability or inability to meet the requirements of the protocol, inter lia, for physical, mental or social reasons, according to the clinical investigator
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federally Funded Healthcare Institution Primary Healthcare Unit No. 163
Novosibirsk
About this study
Official title: Phase I Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, Produced by FSUE SPbSRIVS FMBA, vs. Placebo in Healthy Volunteers
The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers
Read the detailed description
The maximum period of the volunteers' participation in the trial will be 35 ± 2 days. Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period - 28±2 days.
All volunteers are followed by a clinical investigator for 6 months after vaccination outside of this trial with the aim of detecting possible late adverse reactions. If a volunteer has any delayed-type reactions, the volunteer will be invited to the clinic for correction of his/her condition.
- Conditions
- Influenza
- Being tested
- Flu-M Quadro [inactivated split influenza vaccine] with preservative, Flu-M Quadro [inactivated split influenza vaccine] without preservative, Placebo
- Keywords
- influenza, flu, vaccine, Flu-M, FluM Tetra, Tetra, SPbSRIVS, Quadro
- 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 Quadro [inactivated split influenza vaccine] with preservativeBiological
solution for intramuscular injection, 0.5 ml
Flu-M Quadro [inactivated split influenza vaccine] without preservativeBiological
solution for intramuscular injection, 0.5 ml
PlaceboBiological
solution for intramuscular injection, 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| Flu-M Quadro with preservative | Experimental | 25 volunteers were vaccinated with the Flu-M Quadro inactivated split influenza vaccine with a preservative Receives: Biological: Flu-M Quadro [inactivated split influenza vaccine] with preservative |
| Flu-M Quadro without preservative | Experimental | 25 volunteers were vaccinated with the Flu-M Quadro inactivated split influenza vaccine without a preservative Receives: Biological: Flu-M Quadro [inactivated split influenza vaccine] without preservative |
| Placebo | Placebo comparator | 25 volunteers were vaccinated with a Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (local and systemic post-vaccination reactions)
Measured: days 1-7
Incidence of adverse events (systemic post-vaccination reactions)
Measured: days 1-7
Incidence of any serious adverse events during the trial
Measured: days 1-28
Secondary outcomes (5)
The content of specific anti-influenza antibodies in serum
Measured: days 0, 28 after the vaccination
The geometric mean titer (GMT) of antibodies to hemagglutinins of the influenza virus
Measured: days 0, 28 after the vaccination
Seroconversion factor
It shout be more than 2.5 after the vaccination
Measured: days 0, 28
Seroconversion level
Measured: days 0, 28 after the vaccination
Seroprotection level
Measured: days 0, 28 after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start16 Nov 2019
- Primary completion22 Jan 2020
- Study completion24 Jan 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 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
- NCT05152017
- Sponsor's protocol ID
- FMVq-I-001/18
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 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
- Phase I Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, Produced by FSUE SPbSRIVS FMBA, vs. Placebo in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05152017
- Acronym / sponsor ID
- FMVq-I-001/18
- Conditions
- Influenza
- Keywords
- influenza, flu, vaccine, Flu-M, FluM Tetra, Tetra, SPbSRIVS, Quadro
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and SeraOther government
- Study start
- 16 Nov 2019 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 9 Dec 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.
The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers
Detailed description
The maximum period of the volunteers' participation in the trial will be 35 ± 2 days. Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period - 28±2 days.
All volunteers are followed by a clinical investigator for 6 months after vaccination outside of this trial with the aim of detecting possible late adverse reactions. If a volunteer has any delayed-type reactions, the volunteer will be invited to the clinic for correction of his/her condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flu-M Quadro with preservative | Experimental | Biological: Flu-M Quadro [inactivated split influenza vaccine] with preservative25 volunteers were vaccinated with the Flu-M Quadro inactivated split influenza vaccine with a preservative |
| Flu-M Quadro without preservative | Experimental | Biological: Flu-M Quadro [inactivated split influenza vaccine] without preservative25 volunteers were vaccinated with the Flu-M Quadro inactivated split influenza vaccine without a preservative |
| Placebo | Placebo comparator | Biological: Placebo25 volunteers were vaccinated with a Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Voluntarily and personally signed form of informed consent for participation in the trial, before any trial procedure is carried out.
- Verified diagnosis "healthy", at that the clinical investigator shall confirm the absence of pathology on the part of the main organs and systems, previously conducted standard clinical, laboratory and instrumental studies did not reveal any diseases.
- Age between 18 and 60 years old, inclusively.
- Ability to attend all planned visits and all scheduled procedures and studies.
- Willingness of the volunteers to complete Self-Observation Diaries in between their visits to a clinical center.
Key exclusion criteria (17 listed)
- Known hypersensitivity to any of the components of the tested products, as well as to chicken meat or chicken/quail eggs.
- Allergic reaction to any previous influenza vaccination.
- Adverse reaction of severe degree of manifestation or serious adverse reaction to previous influenza vaccine administration.
- Signs of any disease at the time of inclusion in the trial or if less than 4 weeks have expired after recovery.
- Any acute respiratory disease less than 3 months before inclusion in the trial.
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 Quadro [inactivated split influenza vaccine] with preservativesolution for intramuscular injection, 0.5 ml | Biological | Flu-M Quadro with preservative |
| Flu-M Quadro [inactivated split influenza vaccine] without preservativesolution for intramuscular injection, 0.5 ml | Biological | Flu-M Quadro without preservative |
| Placebosolution for intramuscular injection, 0.5 ml | Biological | Placebo |
Primary outcome
Incidence of adverse events (local and systemic post-vaccination reactions)
Time frame: days 1-7
Incidence of adverse events (systemic post-vaccination reactions)
Time frame: days 1-7
Incidence of any serious adverse events during the trial
Time frame: days 1-28
5 secondary outcomes
The content of specific anti-influenza antibodies in serum
Time frame: days 0, 28 after the vaccination
The geometric mean titer (GMT) of antibodies to hemagglutinins of the influenza virus
Time frame: days 0, 28 after the vaccination
Seroconversion factor
Time frame: days 0, 28
Seroconversion level
Time frame: days 0, 28 after the vaccination
Seroprotection level
Time frame: days 0, 28 after the 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 Flu-M Quadro [inactivated split influenza vaccine] with preservative and Flu-M Quadro [inactivated split influenza vaccine] without preservative 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 7 inclusion and 17 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?
Incidence of adverse events (local and systemic post-vaccination reactions) (time frame: days 1-7). The study lists 3 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.