Human InfluenzaPhase 1NCT03448705
Safety of 4Fluart ID Suspension for Injection in Adult Subjects
A Phase 1 study testing 4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted), 4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted) and 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted) in people with Human Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 1 site in Hungary.
Trial summary
The primary objective of the study is to evaluate the safe usability of the study drugs, i.e. 4Fluart ID 1 µg haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml QIV in terms of safety concerns emerged. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Influenza
- What is being tested?
- 4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted), 4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted) and 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHungary
- Study dates
- 31 Jan 2018to 3 Apr 2018
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult persons aged 18 to 59 years, determined on the day of enrolment from both sexes, mentally competent;
- Good health (as determined by vital signs and existing medical condition) or stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or insulin treated), the significance of which, in the opinion of the investigator, will not compromise the subject's participation in the study;
- Female volunteers of childbearing potential upon the decision of the investigator with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and to not become pregnant for the duration of the study;
- Capability of participants to understand and comply with planned study procedures;
- Participants provide written informed consent prior to initiation of study procedures;
- Absence of any exclusion criteria.
Who cannot join
- Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study. Pregnancy with regard to the total duration of the study.
- Hypersensitivity to the active substances or to any of the excipients, such as thiomersal, or any component that may be present in traces, such as egg (ovalbumin), formaldehyde, gentamicin, neomycin, vancomycin or ciprofloxacin determined prior to vaccination;
- Serious complications in the medical history with regard to any previous vaccination: encephalitis/encephalopathy, nonfebrile seizures, Guillain-Barré syndrome, vasculitis, neuritis, facial paresis determined prior to vaccination;
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine determined prior to vaccination;
- Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure with regard to the total duration of the study;
- Immunosuppressive therapy within 36 months prior to vaccination and with regard to the total duration of the study;
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- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids with regard to the total duration of the study;
- Receipt of immunostimulants with regard to the total duration of the study;
- Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination and with regard to the total duration of the study;
- Suspected or known HIV, Hepatitis-B virus (HBV) or Hepatitis-C virus (HCV) infection with regard to the total duration of the study;
- Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;
- Vaccine therapy within 4 weeks prior to vaccination and with regard to the total duration of the study;
- Influenza vaccination (any kind) within 6 months prior to vaccination and with regard to the total duration of the study;
- Experimental drug therapy within 4 weeks prior to vaccination and with regard to the total duration of the study;
- Concomitant participation in another clinical study;
- Any condition which, may interfere with the evaluation of the study (including major protocol deviation with regard to the total duration of the study);
- Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have an effect on the objective decision-making of the volunteer;
- Alcohol or drug abuse of the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label to the Route of Administration, Single-blind to the ID Doses, Randomised, Active-controlled, Parallel Study to Evaluate the Safe Usability of 4Fluart ID Suspension for Injection in Adult Subjects
The primary objective of the study is to evaluate the safe usability of the study drugs, i.e. 4Fluart ID 1 µg haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml QIV in terms of safety concerns emerged.
The secondary objective of the study is to further assess safety in terms of safety parameters, as well as to assess the immunogenicity of 4Fluart ID 1 µg haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml QIV in terms of immunogenicity parameters.
Read the detailed description
Healthy volunteers (male and female) aged 18-59 years were enrolled into the study by signing subject information leaflet and informed consent form. After screening them, subjects complying with inclusion and exclusion criteria were included in the study, randomised and vaccinated with one of the investigational medicinal products assigned by the randomisation list.
Subjects were observed for thirty (30) minutes after vaccination for any immediate reactions. All adverse events (AEs) were collected from the enrolment to Day 21-28. Safety data between Day 0 and Day 7-9 were documented on a Diary card by each subject. Safety assessment were performed based on Day 7-9 and Day 21-28 safety data compared to the baseline on Day 0.
Blood samples for immunogenicity assays were collected immediately before vaccination on Day 0 (pre-vaccination blood samples) and on Day 21-28 (post-vaccination blood samples) in all subjects included in the study and complying with the study procedures. Immunogenicity were evaluated by hemagglutinin inhibition test in order to assess immune response 3-4 weeks after vaccination.
The assessment of safety and immunogenicity of 4Fluart ID 1 µg/0.1 ml QIV and 4Fluart ID 2 µg/0.1 ml QIV was performed in comparison to the authorised 3Fluart, i.e. 3Fluart intramuscular (IM) 6 µg/0.5 ml TIV.
- Conditions
- Human Influenza
- Being tested
- 4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted), 4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted), 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)
- Keywords
- influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)Biological
Also called 4Fluart ID suspension for injection study drug, 4Fluart ID 1 µg/0.1 ml QIV
Route of administration: intradermal, Dosage: 1 μg HA/strain / 0.1 ml, Package: 0.5 ml in one ampoule from which 0.1 ml is equal to a single dose, Dosage regimen: 1 x 0.1 ml, Treatment duration: single dose.
4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)Biological
Also called 4Fluart ID suspension for injection study drug, 4Fluart ID 2 µg/0.1 ml QIV
Route of administration: intradermal, Dosage: 2 μg HA/strain / 0.1 ml, Package: 0.5 ml in one ampoule from which 0.1 ml is equal to a single dose, Dosage regimen: 1 x 0.1 ml, Treatment duration: single dose.
3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)Biological
Also called 3Fluart suspension for injection, 3Fluart IM 6 µg/0.5 ml TIV
Route of administration: intramuscular, Dosage: 6 μg HA/strain / 0.5 ml, Package: 0.5 ml in one ampoule from which a total of 0.5 ml is equal to a single dose, Dosage regimen: 1 x 0.5 ml, Treatment duration: single dose.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Study drug 1 (i.e. 4Fluart ID 1 µg/0.1 ml QIV) | Experimental | Vaccination of 12 subjects will be performed with the intradermal quadrivalent influenza vaccine containing 1 µg haemagglutinin per virus strain in 0.1 ml as a single dose. Receives: Biological: 4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted) |
| Group 2 - Study drug 2 (i.e. 4Fluart ID 2 µg/0.1 ml QIV) | Experimental | Vaccination of 12 subjects will be performed with the intradermal quadrivalent influenza vaccine containing 2 µg haemagglutinin per virus strain in 0.1 ml as a single dose. Receives: Biological: 4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted) |
| Group 3 - Comparator drug (i.e. 3Fluart IM 6 µg/0.5 ml TIV) | Active comparator | Vaccination of 12 subjects will be performed with the intramuscular trivalent influenza vaccine containing 6 µg haemagglutinin per virus strain in 0.5 ml as a single dose. Receives: Biological: 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in terms of safety concenrs emerged
Percentage of subjects reporting safety concerns following vaccination Measurement is based on the assessment of the study investigator by each subject
Measured: Between 0 day (day of vaccination) and 21-28 days after vaccination
Secondary outcomes (3)
Ratio of geometric mean anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
Ratio of Day 21-28 and Day 0 titres Anti-hemagglutinin antibodies are measured by hemagglutinin inhibition test
Measured: Between 0 day (day of vaccination) and 21-28 days after vaccination
Percentage of subjects seroconverted based on anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
Seroconversion is defined as in subjects seronegative at baseline (i.e. HI titre <1:10 at Day 0) a post-vaccination HI titre ≥1:40, and in subjects seropositive at baseline (i.e. HI titre ≥1:10 at Day 0) as minimum of a 4-fold increase in post-vaccination HI titre Anti-hemagglutinin antibodies are measured by hemagglutinin inhibition test
Measured: 0 days (day of vaccination) and 21-28 days after vaccination
Percentage of subjects seroprotected based on anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
The seroprotection rate is defined as a proportion of subjects with HI titre ≥1:40.
Anti-hemagglutinin antibodies are measured by hemagglutinin inhibition test
Measured: 0 days (day of vaccination) and 21-28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start31 Jan 2018
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human 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
- Model description
- According to the objective, as well as the primary endpoints of the study, this is a Phase I study, open-label to the route of administration, single-blind to the ID doses, randomised, active-controlled that will be conducted in three parallel groups. Three visits will be performed in the study: on Day 0, Day 7-9 and Day 21-28. Pre-vaccination and post-vaccination serum samples are to be taken on Day 0 and Day 21-28. Adverse events will be documented between the enrollment and Day 21-28.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluart Innovative Vaccine Ltd, Hungary
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orsolya Gyurján, Study director, Fluart Innovative Vaccines Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448705
- Sponsor's protocol ID
- 4Fluart-H-21
- Status last verified
- Feb 2021
- First submitted
- 26 Sep 2017
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label to the Route of Administration, Single-blind to the ID Doses, Randomised, Active-controlled, Parallel Study to Evaluate the Safe Usability of 4Fluart ID Suspension for Injection in Adult Subjects
- ClinicalTrials.gov ID
- NCT03448705
- Acronym / sponsor ID
- 4Fluart-H-21
- Conditions
- Human Influenza
- Keywords
- influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 28 Feb 2018 (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 primary objective of the study is to evaluate the safe usability of the study drugs, i.e. 4Fluart ID 1 µg haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml QIV in terms of safety concerns emerged.
The secondary objective of the study is to further assess safety in terms of safety parameters, as well as to assess the immunogenicity of 4Fluart ID 1 µg haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 µg haemagglutinin (HA)/0.1 ml QIV in terms of immunogenicity parameters.
Detailed description
Healthy volunteers (male and female) aged 18-59 years were enrolled into the study by signing subject information leaflet and informed consent form. After screening them, subjects complying with inclusion and exclusion criteria were included in the study, randomised and vaccinated with one of the investigational medicinal products assigned by the randomisation list.
Subjects were observed for thirty (30) minutes after vaccination for any immediate reactions. All adverse events (AEs) were collected from the enrolment to Day 21-28. Safety data between Day 0 and Day 7-9 were documented on a Diary card by each subject. Safety assessment were performed based on Day 7-9 and Day 21-28 safety data compared to the baseline on Day 0.
Blood samples for immunogenicity assays were collected immediately before vaccination on Day 0 (pre-vaccination blood samples) and on Day 21-28 (post-vaccination blood samples) in all subjects included in the study and complying with the study procedures. Immunogenicity were evaluated by hemagglutinin inhibition test in order to assess immune response 3-4 weeks after vaccination.
The assessment of safety and immunogenicity of 4Fluart ID 1 µg/0.1 ml QIV and 4Fluart ID 2 µg/0.1 ml QIV was performed in comparison to the authorised 3Fluart, i.e. 3Fluart intramuscular (IM) 6 µg/0.5 ml TIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- According to the objective, as well as the primary endpoints of the study, this is a Phase I study, open-label to the route of administration, single-blind to the ID doses, randomised, active-controlled that will be conducted in three parallel groups. Three visits will be performed in the study: on Day 0, Day 7-9 and Day 21-28. Pre-vaccination and post-vaccination serum samples are to be taken on Day 0 and Day 21-28. Adverse events will be documented between the enrollment and Day 21-28.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Study drug 1 (i.e. 4Fluart ID 1 µg/0.1 ml QIV) | Experimental | Biological: 4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)Vaccination of 12 subjects will be performed with the intradermal quadrivalent influenza vaccine containing 1 µg haemagglutinin per virus strain in 0.1 ml as a single dose. |
| Group 2 - Study drug 2 (i.e. 4Fluart ID 2 µg/0.1 ml QIV) | Experimental | Biological: 4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)Vaccination of 12 subjects will be performed with the intradermal quadrivalent influenza vaccine containing 2 µg haemagglutinin per virus strain in 0.1 ml as a single dose. |
| Group 3 - Comparator drug (i.e. 3Fluart IM 6 µg/0.5 ml TIV) | Active comparator | Biological: 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)Vaccination of 12 subjects will be performed with the intramuscular trivalent influenza vaccine containing 6 µg haemagglutinin per virus strain in 0.5 ml as a single dose. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult persons aged 18 to 59 years, determined on the day of enrolment from both sexes, mentally competent;
- Good health (as determined by vital signs and existing medical condition) or stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or insulin treated), the significance of which, in the opinion of the investigator, will not compromise the subject's participation in the study;
- Female volunteers of childbearing potential upon the decision of the investigator with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and to not become pregnant for the duration of the study;
- Capability of participants to understand and comply with planned study procedures;
- Participants provide written informed consent prior to initiation of study procedures;
Key exclusion criteria (18 listed)
- Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study. Pregnancy with regard to the total duration of the study.
- Hypersensitivity to the active substances or to any of the excipients, such as thiomersal, or any component that may be present in traces, such as egg (ovalbumin), formaldehyde, gentamicin, neomycin, vancomycin or ciprofloxacin determined prior to vaccination;
- Serious complications in the medical history with regard to any previous vaccination: encephalitis/encephalopathy, nonfebrile seizures, Guillain-Barré syndrome, vasculitis, neuritis, facial paresis determined prior to vaccination;
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine determined prior to vaccination;
- Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure with regard to the total duration of 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 |
|---|---|---|
| 4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)Also: 4Fluart ID suspension for injection study drug, 4Fluart ID 1 µg/0.1 ml QIVRoute of administration: intradermal, Dosage: 1 μg HA/strain / 0.1 ml, Package: 0.5 ml in one ampoule from which 0.1 ml is equal to a single dose, Dosage regimen: 1 x 0.1 ml, Treatment duration: single dose. | Biological | Group 1 - Study drug 1 (i.e. 4Fluart ID 1 µg/0.1 ml QIV) |
| 4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)Also: 4Fluart ID suspension for injection study drug, 4Fluart ID 2 µg/0.1 ml QIVRoute of administration: intradermal, Dosage: 2 μg HA/strain / 0.1 ml, Package: 0.5 ml in one ampoule from which 0.1 ml is equal to a single dose, Dosage regimen: 1 x 0.1 ml, Treatment duration: single dose. | Biological | Group 2 - Study drug 2 (i.e. 4Fluart ID 2 µg/0.1 ml QIV) |
| 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)Also: 3Fluart suspension for injection, 3Fluart IM 6 µg/0.5 ml TIVRoute of administration: intramuscular, Dosage: 6 μg HA/strain / 0.5 ml, Package: 0.5 ml in one ampoule from which a total of 0.5 ml is equal to a single dose, Dosage regimen: 1 x 0.5 ml, Treatment duration: single dose. | Biological | Group 3 - Comparator drug (i.e. 3Fluart IM 6 µg/0.5 ml TIV) |
Primary outcome
Safety in terms of safety concenrs emerged
Time frame: Between 0 day (day of vaccination) and 21-28 days after vaccination
Percentage of subjects reporting safety concerns following vaccination Measurement is based on the assessment of the study investigator by each subject
3 secondary outcomes
Ratio of geometric mean anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
Time frame: Between 0 day (day of vaccination) and 21-28 days after vaccination
Percentage of subjects seroconverted based on anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
Time frame: 0 days (day of vaccination) and 21-28 days after vaccination
Percentage of subjects seroprotected based on anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
Time frame: 0 days (day of vaccination) and 21-28 days after 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 3 Mar 2021.
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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.
Orsolya Gyurján study director
Fluart Innovative Vaccines Ltd.
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 4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted), 4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted) and 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted) in people with Human Influenza, run by Fluart Innovative Vaccine Ltd, Hungary at 1 site in Hungary.
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 6 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 3 Mar 2021. 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 Hungary. 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 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?
Safety in terms of safety concenrs emerged (time frame: Between 0 day (day of vaccination) and 21-28 days after vaccination). 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 3 Mar 2021.