EMA: Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines
This document provides information on items to be considered in the design and conduct of studies to support the safety and efficacy of immunological veterinary medicinal products (IVMPs) in finfish. The guideline outlines important items to take into account for both laboratory scale size and field trials so that the studies are representative of the safety and efficacy of the vaccine when administered in accordance with its intended use (e.g. type of fish to be used; water conditions, method of administration, use of control groups etc). The guideline also outlines aspects to be considered in the determination of the duration of immunity for vaccines intended for use in fish.