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Safety of 4Fluart ID Suspension for Injection in Adult Subjects

NCT03448705 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-03-03

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Fluart Innovative Vaccine Ltd, Hungary

    lead INDUSTRY

Principal Investigators

  • Orsolya Gyurján · Fluart Innovative Vaccines Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2018-04-03
Completion
2018-04-03

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448705 on ClinicalTrials.gov