Phase 1Completed
Safety of 4Fluart ID Suspension for Injection in Adult Subjects
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
- Sponsor
- Fluart Innovative Vaccine Ltd, Hungary (Industry)
- Enrolment
- 36 enrolled
- Conditions
- Human Influenza
- Interventions
- 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)
- Ages
- adults
- Registry
- NCT03448705
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Safety in terms of safety concenrs emerged
History
Last registry update
Primary completion
Registered
Started