Immunization of healthy people against influenza virus infections.
Conditions
Interventions
Trade Name: FluvalAB vaccine
Product Name: FluvalAB vaccine
Pharmaceutical Form: Injection*
INN or Proposed INN: Vaccinum influenzae inactivatum
Other descriptive name: Influenza A/New Caledonia/20/99
Sponsors
Omninvest Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adult volunteers above 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergy on any ingredient, pregnancy, age under 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Verification of the fact that in consequence of the vaccination ratio of seroconversion was greater than 30-40% (in dependence of the age category);Secondary Objective: Verification of the fact that in consequence of the vaccination increase of geometric mean titer was greater than 2-2,5 (in dependence of the age category);Primary end point(s): Verification of the fact that in consequence of the vaccination ratio of seroconversion was greater than 30-40% (in dependence of the age category). Verification of the fact that in consequence of the vaccination increase of geometric mean titer was greater than 2-2,5 (in dependence of the age category). | — |
Countries
Hungary
Outcome results
None listed