The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered once the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
122
15 µg antigen/strain: * A/California/07/2009 (H1N1) - like strain * A/Perth/16/2009 (H3N2) - like strain * B/Brisbane/60/2008- like strain MF59 adjuvant 9.75µg ai 0.5ml
Medical School Hannover
Hanover, Germany
Seroconversion and Seroprotection after 21 days
The observed percentage of seroconversion and seroprotection, as well as the observed GMR (measured by HI) in transplanted patients at day 21 will be compared with the thresholds from the guideline for adults aged over 60 (as outlined above). This study is successful, if all three point estimates pass the corresponding efficacy criteria at day 21. For descriptive purpose two-sided 95%-confidence intervals for the rates and the GMR at day 21 will be presented.
Time frame: 21 days
comparison of vaccine efficacy in transplanted versus healthy subjects
1\. The immune response of the H1N1 vaccine is at least as effective in transplanted patients as in the healthy volunteers after one administration. For orientation in the assessment a non-inferiority-margin of 0.45 for the ratio of the geometric mean titers (GMTs) of transplanted patients and age-matched healthy volunteers at day 21 will be used and reflects what can be demonstrated with given sample size.
Time frame: 21 and 42 days
assessment of primary and secondary outcomes with the two other strains
The primary and the first main secondary objective will also be evaluated for the other two virus strains (H3N2 and type B) of the trivalent vaccination.
Time frame: 21 and 42 days
safety issues as number of participants with adverse events
The safety of the study vaccine will be analyzed based on number of subjects exposed to the vaccine with respect to (1) solicited events within 7 days after injection; and (2) non-solicited adverse events at least 21 days after injection. Unsolicited events will include SAEs, AEIs (e.g. neuritis, convulsions, severe allergic reactions, angioedema, non-infectious encephalitis, vasculitis, Guillain-Barrè syndrome, demyelination, Bell's palsy), all other non-solicited AEs, which are routinely collected including onset of chronic diseases.
Time frame: 21 and 42 days and 9 months
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