Last updated on March 2018

Safety of 4Fluart Intradermal Suspension for Injection (Influenza Vaccine Whole-virion Inactivated Adjuvanted) in Adult Subjects

Brief description of study

The primary objective of the study is to evaluate the safe usability of the study drugs, i.e. 4Fluart ID 1 g haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 g 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 g haemagglutinin (HA)/0.1 ml QIV and 4Fluart ID 2 g haemagglutinin (HA)/0.1 ml QIV in terms of immunogenicity parameters.

Detailed Study Description

Healthy volunteers (male and female) aged 18-59 years will be enrolled into the study by signing subject information leaflet and informed consent form. After screening them, subjects complying with inclusion and exclusion criteria will be included in the study, randomised and vaccinated with one of the investigational medicinal products assigned by the randomisation list.

Subjects will be observed for thirty (30) minutes after vaccination for any immediate reactions. All adverse events (AEs) will be collected from the enrolment to Day 21-28. Safety data between Day 0 and Day 7-9 will be documented on a Diary card by each subject. Safety assessment will be performed based on Day 7-9 and Day 21-28 safety data compared to the baseline on Day 0.

Blood samples for immunogenicity assays will be 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 will be 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 g/0.1 ml QIV and 4Fluart ID 2 g/0.1 ml QIV will be performed in comparison to the authorised 3Fluart, i.e. 3Fluart intramuscular (IM) 6 g/0.5 ml TIV.

Clinical Study Identifier: NCT03448705

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Drug Research Center

Balatonfüred, Hungary
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