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.

Current version - effective from 01/08/2023

Guideline on clinical evaluation of vaccines - Revision 1

AdoptedReference Number: EMEA/CHMP/VWP/164653/05 Rev. 1Legal effective date: 01/08/2023

Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals

AdoptedConsultation dates: 19/07/2024 to 31/10/2024Reference Number: EMA/52912/2025Summary:

This Addendum to the guideline provides guidance on clinical studies to be conducted in immunocompromised individuals before or after initial marketing authorization of vaccines in order to support recommendations for use in the Product Information. 

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

 

Revision 1

Concept paper on the development of an addendum to the Guideline on clinical development of vaccines on clinical trials for vaccines for immunocompromised individuals

Draft: consultation closedConsultation dates: 01/11/2023 to 01/01/2024Reference Number: EMA/CHMP/453562/2023Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Keywords: immunocompromised, clinical trials, immunogenicity, vaccines

Guideline on clinical evaluation of vaccines - Revision 1

AdoptedReference Number: EMEA/CHMP/VWP/164653/05 Rev. 1Legal effective date: 01/08/2023

Draft guideline on clinical evaluation of vaccines - Revision 1

Draft: consultation closedConsultation dates: 26/04/2018 to 30/10/2018Reference Number: EMEA/CHMP/VWP/164653/05 Rev. 1Summary:

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. The draft guideline includes specific considerations for clinical trials with vaccines in special populations, such as pregnant women or the elderly. It also adds considerations to priming and boosting strategies, including the option of heterologous prime-boost, which entails administration of one type of vaccine first followed by a different type of vaccine for the same pathogen later.

Concept paper on revision of the guideline on clinical development of vaccines

Draft: consultation closedConsultation dates: 23/06/2017 to 30/09/2017Reference Number: EMA/CHMP/VWP/124350/2017Summary:

The Guideline on clinical evaluation of vaccines (EMEA/CHMP/VWP/164653/2005) was developed during 2005-2006 and came into operation in 2007. It covers the design of clinical development programmes for new vaccines that are intended to provide pre- and post-exposure prophylaxis against infectious diseases. Some of the guidance provided is also relevant to the further development of licensed vaccines (i.e. generation of clinical data to support changes to the prescribing information in the post-authorisation period). Much of what this guideline says is still fully relevant to current vaccine clinical development but a revision is proposed to address issues that have come to light since it came into operation.

First version

Guideline on clinical evaluation of new vaccines

AdoptedReference Number: EMEA/CHMP/VWP/164653/2005Legal effective date: 01/02/2007

Note for guidance on the clinical evaluation of vaccines

Reference Number: CHMP/VWP/164653/2005

Superseded documents

Annex to the guideline on clinical evaluation of new vaccines: summary of product characteristics requirements - Superseded

AdoptedReference Number: EMEA/CHMP/VWP/382702/2006Legal effective date: 01/02/2007