THE CLINICAL DEVELOPMENT PROCESS FOR A NOVEL PREVENTIVE VACCINE: AN OVERVIEW


This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA).

The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed.

The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.

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