Abstract:
The epidemiological situation referring to a number of infectious diseases, presenting manageable infections, requires more careful oversight, beginning with the preclinical and clinical studies, vaccine production, control of technological process and the serial production of the preparation and
finishing with applying the product by the consumer. The effectiveness of immunization depends on a number of factors arising from the choice of the
design of the drug clinical trials. Widely used in the medical practice newly created domestic vaccine preparations and oversea vaccine preparations,
presented for the registration for the first time, require careful clinical study to examine their quality by defining security settings and immunologic
efficiency. The expertise of immunobiological preparations is based on the evaluation of safety and efficacy, by which by the ratio of risk-benefit of
the examined drug is determined. So, it is necessary to find the optimal design of the clinical trial that will objectively determine the ratio between the
security and antigenic activity of the drug. The selection of volunteers for a clinical study is carried out on the basis of inclusion and exclusion criterias,
taking into account legal and ethical principles, based on existing national requirements for the quality of medicines, and the principles of Helsinki
Declaration. During the clinical trials on vaccine preparations the selection of the optimal dosage and immunization scheme, the establishment of
preventive vaccine effectiveness, the exploration of the possibility of expanding the indications for medical use and the identification of previously
unknown side effects of registered vaccine preparations are performed. The organization and conduct of clinical trials of immunobiological preparations is a fundamental component in the system of epidemiological monitoring of vaccine preventable infections. A properly planned and administered
clinical trial of the vaccine products is a guarantee of the effectiveness of the population vaccination.
