SELECTED REGULATORY AND SCIENTIFIC TOPICS FOR CANDIDATE ROTAVIRUS VACCINE DEVELOPMENT

Various aspects of the development of rotavirus vaccine candidates are discussed. As is true with other vaccines, comprehensive testing must be done to detect the possible presence of adventitious agents in the vaccine and seed preparations. Consideration must also be given to ot her biologic materials that come in contact with the vaccine preparati on during production to prevent the introduction of contaminants. The clinical testing of rotavirus vaccines from early safety and immunogen icity studies through final efficacy studies is also discussed. Issues surrounding coadministration of investigational rotavirus vaccines wi th US-licensed vaccines are ideally addressed before initiation of eff icacy trials. Other subjects discussed are identification of correlate s of protection, multivalent vaccines, foreign efficacy trials, safety data, and statistical considerations. Sponsors of investigational vac cines are urged to contact the Food and Drug Administration for guidan ce during the development process, especially before the investigation al new drug application and pivotal efficacy trial stages.