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EMVI-TRIAL-PROTOCOLS

STRATEGIC SUPPORT MEASURES (INCO)

European Malaria Vaccine Clinical Trial Protocols
Framework programme:
5
Project number:
ICA4-1999-50066
EC contribution:
€ 74 800
Duration:
12 months
Type:
AM
Starting date:
2001

Summary:

Following consultations with members of the core research groups concerned with malaria vaccine development, this consortium (EMVI and AMVTN) proposes to convene a series of workshops with the participation of the pharmaceutical industry. The aim is to develop standardised trial protocols for phase I and possible phase II clinical trials of pre-erythrocytic, erythrocytic and transmission-blocking malaria vaccine to be tested in a European facility. The development of standardised clinical protocols will follow the guidelines set forth by the international congress on harmonisation (ICH), and will involve consultations with the European agency for the evaluation of medicinal products and assistance from the European forum for good clinical practice, especially the chair concerning ethics.

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