NCT03448705 - Safety of 4Fluart ID Suspension for Injection in Adult Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2018

Primary Completion Date

April 3, 2018

Study Completion Date

April 3, 2018

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.

Trial Locations (1)

H-8230

Drug Research Center, Balatonfüred