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