Safety of 4Fluart ID Suspension for Injection in Adult Subjects

NCT03448705 | Completed Phase 1

• 1 other identifier: 4Fluart-H-21
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Influenza

Keywords

influenza

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  0 days (day of vaccination) and 21-28 days after vaccination

Study Arms (3)

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.

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.

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.

Biological: 3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)

Interventions

4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted) BIOLOGICAL

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.

Also known as: 4Fluart ID suspension for injection study drug, 4Fluart ID 1 µg/0.1 ml QIV

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) BIOLOGICAL

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.

Also known as: 4Fluart ID suspension for injection study drug, 4Fluart ID 2 µg/0.1 ml QIV

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) BIOLOGICAL

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.

Also known as: 3Fluart suspension for injection, 3Fluart IM 6 µg/0.5 ml TIV

Group 3 - Comparator drug (i.e. 3Fluart IM 6 µg/0.5 ml TIV)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fluart Innovative Vaccine Ltd, Hungary: lead

Study Sites (1)

Drug Research Center

Balatonfüred, Veszprém megye, H-8230, Hungary

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Injections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Orsolya Gyurján

  Fluart Innovative Vaccines Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study is single-blind (blinded for the participant).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: February 28, 2018
• Study Start: January 31, 2018
• Primary Completion: April 3, 2018
• Study Completion: April 3, 2018
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

HU (1)