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SOME ASPECTS OF THE DEVELOPMENT OF CLINICAL TRIALS OF NEW VACCINES


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Abstract

Actual trends in the development of new combination vaccines have led to the need to revision some of the requirements for conducting clinical trials to assess their effectiveness and safety. This review presents an analysis of current guidelines for design preclinical and clinical trials. The main attention is paid to the requirements for preclinical research programs and protocols for clinical trials for combined vaccines. The main stages of the study of vaccine efficacy and safety and the main principles for substantiating the scope of the necessary studies are presented.


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