Back to resultsSafety of 4Fluart ID Suspension for Injection in Adult Subjects
Primary Purpose
Human Influenza
Status
Completed
Phase
Phase 1
Locations
Hungary
Study Type
Interventional
Intervention
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)
Sponsored by
About this trial
This is an interventional prevention trial for Human Influenza focused on measuring influenza
Eligibility Criteria
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.
Sites / Locations
- Drug Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group 1 - Study drug 1 (i.e. 4Fluart ID 1 µg/0.1 ml QIV)
Group 2 - Study drug 2 (i.e. 4Fluart ID 2 µg/0.1 ml QIV)
Group 3 - Comparator drug (i.e. 3Fluart IM 6 µg/0.5 ml TIV)
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT03448705
First Posted
September 26, 2017
Last Updated
February 28, 2021
Sponsor
Fluart Innovative Vaccine Ltd, Hungary
1. Study Identification
Unique Protocol Identification Number
NCT03448705
Brief Title
Safety of 4Fluart ID Suspension for Injection in Adult Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
April 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fluart Innovative Vaccine Ltd, Hungary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Influenza
Keywords
influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The study is single-blind (blinded for the participant).
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - Study drug 1 (i.e. 4Fluart ID 1 µg/0.1 ml QIV)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 - Study drug 2 (i.e. 4Fluart ID 2 µg/0.1 ml QIV)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3 - Comparator drug (i.e. 3Fluart IM 6 µg/0.5 ml TIV)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)
Other Intervention Name(s)
4Fluart ID suspension for injection study drug, 4Fluart ID 1 µg/0.1 ml QIV
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)
Other Intervention Name(s)
4Fluart ID suspension for injection study drug, 4Fluart ID 2 µg/0.1 ml QIV
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)
Other Intervention Name(s)
3Fluart suspension for injection, 3Fluart IM 6 µg/0.5 ml TIV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety in terms of safety concenrs emerged
Description
Percentage of subjects reporting safety concerns following vaccination Measurement is based on the assessment of the study investigator by each subject
Time Frame
Between 0 day (day of vaccination) and 21-28 days after vaccination
Secondary Outcome Measure Information:
Title
Ratio of geometric mean anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
Description
Ratio of Day 21-28 and Day 0 titres Anti-hemagglutinin antibodies are measured by hemagglutinin inhibition test
Time Frame
Between 0 day (day of vaccination) and 21-28 days after vaccination
Title
Percentage of subjects seroconverted based on anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
Description
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
Time Frame
0 days (day of vaccination) and 21-28 days after vaccination
Title
Percentage of subjects seroprotected based on anti-hemagglutinin antibody titres, for A/H1N1, A/H3N2, B strains
Description
The seroprotection rate is defined as a proportion of subjects with HI titre ≥1:40.
Anti-hemagglutinin antibodies are measured by hemagglutinin inhibition test
Time Frame
0 days (day of vaccination) and 21-28 days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orsolya Gyurján
Organizational Affiliation
Fluart Innovative Vaccines Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Drug Research Center
City
Balatonfüred
State/Province
Veszprém
ZIP/Postal Code
H-8230
Country
Hungary
12. IPD Sharing Statement
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Safety of 4Fluart ID Suspension for Injection in Adult Subjects
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