Safety of 4Fluart ID Suspension for Injection in Adult Subjects

February 28, 2021 updated by: Fluart Innovative Vaccine Ltd, Hungary

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Veszprém
      • Balatonfüred, Veszprém, Hungary, H-8230
        • Drug Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 - Study drug 1 (i.e. 4Fluart ID 1 µg/0.1 ml QIV)
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.
Biological: 4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)
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.
Other Names:
  • 4Fluart ID suspension for injection study drug
  • 4Fluart ID 1 µg/0.1 ml QIV
Experimental: Group 2 - Study drug 2 (i.e. 4Fluart ID 2 µg/0.1 ml QIV)
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.
Biological: 4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)
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.
Other Names:
  • 4Fluart ID suspension for injection study drug
  • 4Fluart ID 2 µg/0.1 ml QIV
Active Comparator: Group 3 - Comparator drug (i.e. 3Fluart IM 6 µg/0.5 ml TIV)
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.
Biological: 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)
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.
Other Names:
  • 3Fluart suspension for injection
  • 3Fluart IM 6 µg/0.5 ml TIV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Between 0 day (day of vaccination) and 21-28 days after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Ratio of Day 21-28 and Day 0 titres Anti-hemagglutinin antibodies are measured by hemagglutinin inhibition test
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
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
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

The seroprotection rate is defined as a proportion of subjects with HI titre ≥1:40.

Anti-hemagglutinin antibodies are measured by hemagglutinin inhibition test
0 days (day of vaccination) and 21-28 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fluart Innovative Vaccine Ltd, Hungary

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Orsolya Gyurján, Fluart Innovative Vaccines Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4Fluart-H-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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