Clinical evaluation of new vaccines - Scientific guideline
This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases. It includes considerations for trials intended to document the safety, immunogenicity and efficacy of new candidate vaccines and to support changes in the prescribing information of licensed vaccines. It also considers the need for and use of vaccine effectiveness studies.
Keywords: vaccine, antigen, adjuvant, humoral immune response, cellular immune response, vaccination schedule, immunogenicity studies, protective efficacy, effectiveness, safety, immune correlates of protection.
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Concept paper on the development of an addendum to the Guideline on clinical development of vaccines on clinical trials for vaccines for immunocompromised individuals (PDF/185.17 KB) (new)
Draft: consultation open
First published: 03/11/2023
Consultation dates: 01/11/2023 to 01/01/2024
EMA/CHMP/453562/2023 -
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Guideline on clinical evaluation of vaccines - Revision 1 (PDF/401.6 KB)
Adopted
First published: 01/02/2023
Legal effective date: 01/08/2023
EMEA/CHMP/VWP/164653/05 Rev. 1 -
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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