The design of vaccine clinical trials

• Vaccines are subjected to clinical trials in the same way as other pharmaceutical medicines to establish their safety and efficacy before being licensed for use.
• Clinical trials use:
  • randomised
  • double-blind
  • placebo-controlled protocols
• Subjects are split into groups in a randomised way in which neither the subjects nor the researchers know which group they are in to prevent biased interpretation of the results.
• One group of subjects receives the vaccine, while the second group receives a placebo control to ensure valid comparisons.
• At the end of the trial, results from the two groups, which must be of a suitable size to reduce the magnitude of experimental error are compared to determine whether there are any statistically significant differences between the groups.