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• W2091731210 abstract "In this review, we consider the issues impacting conduct and design of dengue vaccine trials with reference to the recently published World Health Organization Guidelines for Conduct of Clinical Trials of Dengue Vaccines in Endemic Areas. We discuss logistic, scientific and ethical challenges concerning evaluation and introduction of dengue vaccines; these range from randomized trials that establish proof of concept of vaccine efficacy, to post-proof of concept trials, particularly demonstration projects likely to be required for licensure or for the introduction of an already licensed vaccine into public use. We clarify and define the meaning of proof of concept in the clinical trial context and the meaning of terms phase 2b, phase 3b and demonstration project, which are commonly used but have not been defined well in the clinical literature." @default.
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• W2091731210 date "2010-10-01" @default.
• W2091731210 modified "2023-09-28" @default.
• W2091731210 title "Dengue vaccine trial guidelines and role of large-scale, post proof-of-concept demonstration projects in bringing a dengue vaccine to use in dengue endemic areas" @default.
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• W2091731210 doi "https://doi.org/10.4161/hv.6.10.13018" @default.
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