The pharmacodynamic effect of the encephalitis, tick borne suspension for injection consists of the induction of a sufficiently high concentration of anti-TBE antibody to provide protection against the TBE virus.
The protection rate of the previous generation TBE vaccine has been determined during a continuous surveillance as performed among the total Austrian population since 1984. In this surveillance a protection rate of above 90% after the second vaccination and above 97% after completion of the primary vaccination schedule (3 doses) was calculated.
Based on a follow up surveillance performed among the total Austrian population for the years 2000 to 2006, a protection rate of 99% was calculated with no statistically significant difference between age groups in regularly vaccinated persons. The protection rate is at least as high after the first two vaccinations, following the conventional and rapid vaccination, i.e., before completion of the basic vaccination scheme by the third vaccination. In those with a record of irregular vaccination the protection rate is significantly lower.
Not applicable.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.
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