Immunization of healthy people against influenza virus infections. MedDRA version: 9.1 Level: LLT Classification code 10059429 Term: Influenza immunisation
Conditions
Sponsors
Omninvest Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adult volunteers between 18-60 years and over 60 years, both males and females. Full contractual capacity. Negative pregnancy test in case of women with childbearing capacity. Informed consent of the volunteers. Absence of exclusion criteria. 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 egg or on any ingredient of the vaccine. Pregnancy or breast feeding. History of Guillain-Barré syndrome Immunsuppressive therapy in 36 month prior to clinical trial. Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic or renal disease, gongestive heart failure Corticosteroid therapy in progress. Vaccination in 4 weeks prior to clinical trial. Flu vaccination in 6 month prior to clinical trial. Acute disease and/or auxillary temperature >= 37°C within the past 3 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of immunogenicity of the vaccine by serology testing from blood samples taken before and 21-28 days after vaccination. ;Secondary Objective: Assessment of safety and tolerability of the vaccine on the basis of adverse events.;Primary end point(s): Assessment of the fact that in consequence of the vaccination ratio of seroconversion was greater than 40% and 30% in age groups respectively. Assessment of the fact that in consequence of the vaccination increase in geometric mean titer was greater than 2,5 and 2 in age groups respectively. Assessment of the fact that in consequence of the vaccination ratio of HAI titres >= 1:40 was greater than 70 and 60 % in age groups respectively. | — |
Countries
Hungary
Outcome results
None listed