Vaccine Development Process Map

Study design considerations

  • Safety, reactogenicity and contra-indications
  • Immunogenicity data
  • Correlates of protection
  • Vaccine effect on infectiousness (VE1)
  • Vaccine effect on progression (VEP)
  • Epidemiology
  • Target population
  • Statistical powering
  • Country/ies
  • Age group(s)/life course stage
  • Previous pathogen/vaccine exposures
  • Statistical analyses – consideration of experimental design, effect sizes, sample sizes
  • Vaccine dosage schedules
  • Prime / boost
  • Dose size
  • Interference and co-administration with other vaccines
  • Route of administration
  • Product presentation
  • Product formulation (vial/size, fill volume, concentration)
  • "Size of trial"; considerations
  • Confidence measures