Microbiology and Infectious Diseases Resources

Clinical Evaluation—Vaccines

Trials and BLA (Biologics License Application)-Enabling Activities

Phase 1 trial (Small human trial to evaluate safety and immunogenicity)

Phase 2 trial (Larger human trial to evaluate safety and efficacy)

Phase 3 trial (Definitive assessment of safety and efficacy in a large population)

Phase 4 trial (Determine safety over time; evaluate other uses)

Support for international clinical studies

Support for clinical programs (information only)

• Clinical agents repository
• Clinical research operations and management support (CROMS)
• Regulatory affairs support
• Statistics and data coordination

DMID Clinical Research Policies and Procedures