Avian influenza and seasonal influenza
Conditions
Brief summary
Primary outcome measure: Seroconversion proportion in all study subjects 3 weeks after the second dose given at least 21 days after the first dose, as assessed by the microneutralization test
Detailed description
Rate of seroconversion defined as the percentage of subjects with either a pre-vaccination MNT titer < 1:10 and a post vaccination MNT titer ≥ 1:80 or a pre-vaccination MNT titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer., Geometric mean titers at pre- and post-vaccination, Detectable increase in T cell (CD4+ and CD8+) responses against H5N1 virus specific antigens in avian influenza virus vaccinated individuals
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: Seroconversion proportion in all study subjects 3 weeks after the second dose given at least 21 days after the first dose, as assessed by the microneutralization test | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of seroconversion defined as the percentage of subjects with either a pre-vaccination MNT titer < 1:10 and a post vaccination MNT titer ≥ 1:80 or a pre-vaccination MNT titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer., Geometric mean titers at pre- and post-vaccination, Detectable increase in T cell (CD4+ and CD8+) responses against H5N1 virus specific antigens in avian influenza virus vaccinated individuals | — |
Countries
Finland