Clinical evaluation of new vaccines - Scientific guideline
This document covers the clinical evaluation of vaccines for pre- and post-exposure prophylaxis against infectious diseases. It is primarily intended to assist applicants and competent authorities to design, and evaluate data from, appropriate clinical development programmes. It addresses studies to be performed during the clinical development of new vaccines. Read together with the
summary of product characteristics requirements
Keywords: Vaccines, humoral immune response, cellular immune response, vaccination schedule, immunogeicity studies, protective efficacy, effectiveness, safety, summary of product characteristics (SmPC) requirements
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Draft guideline on clinical evaluation of vaccines - Revision 1 (PDF/448.17 KB)
Draft: consultation closed
First published: 26/04/2018
Last updated: 26/04/2018
Consultation dates: 26/04/2018 to 30/10/2018
EMEA/CHMP/VWP/164653/05 Rev. 1 -
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Concept paper on revision of the guideline on clinical development of vaccines (PDF/101.15 KB)
Draft: consultation closed
First published: 23/06/2017
Last updated: 23/06/2017
Consultation dates: 23/06/2017 to 30/09/2017
EMA/CHMP/VWP/124350/2017
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Guideline on clinical evaluation of new vaccines (PDF/102.04 KB)
Adopted
First published: 18/10/2006
Last updated: 18/10/2006
Legal effective date: 01/02/2007
EMEA/CHMP/VWP/164653/2005 -
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Note for guidance on the clinical evaluation of vaccines (PDF/236.49 KB)
First published: 17/05/2005
Last updated: 17/05/2005
CHMP/VWP/164653/2005