Safety of 4Fluart ID Suspension for Injection in Adult Subjects
Condition: Human Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): 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)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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.; 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.; 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 intervention name(s): 4Fluart ID suspension for injection study drug; 4Fluart ID 1 µg/0.1 ml QIV; 4Fluart ID suspension for injection study drug; 4Fluart ID 2 µg/0.1 ml QIV; 3Fluart suspension for injection; 3Fluart IM 6 µg/0.5 ml TIV
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Single (Participant)
Primary purpose: Prevention
Keywords: influenza