Work Package 2

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international vaccine institute

Work package 2 (WP2): Clinical Trial Sponsor, Capacity Building, and Training

WP 2 Lead: International Vaccine Institute (IV)

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Objectives

1. To ensure a successful start-up, execution, and completion of the clinical trial, as a clinical trial sponsor
2. Leverage the existing African clinical trial sites network to assess the study sites and prepare the study sites for the ICH-GCP-compliant study conduct
3. Build a regulatory pathway and consultation with the Maturity Level 3 (ML3) National Regulatory Authority (NRA) to license a Chikungunya vaccine in Africa