• Vaccine Clinical Development is an integrated part of the overall process of vaccine development, which involves clinical trials in which study participants are usually prospectively and randomly allocated to receive the vaccine candidate or a control vaccine
  • Participants are then actively followed to generate information on safety, and often immune responses and/or cases of the target disease
  • Clinical development starts with small phase 1 studies in tens or hundreds of volunteers
  • In phase 2 volunteers in the target population are studies for safety and evidence of a desired effect, often an immune response
  • In phase 3 pivotal studies will generally examine prevention of the target disease with at least 3000 participants receiving the vaccine candidate 
  • The key outputs are reports for regulatory agencies, policy makers and health care workers to support marketing approval and appropriate ways to use the vaccine
  • Clinical trial designs and results are made public through registries and peer-reviewed publications