Table 1

Power estimates for primary and key secondary efficacy analyses

ObjectiveEnd point at day 74 vedolizumab vs placeboAssumed response rateSample size*Power (%)
PrimaryHBV seroconversionPlacebo: 90%
Vedolizumab: 90%
Placebo: 55†
Vedolizumab: 55
80
Key secondaryOCV seroconversionPlacebo: 85%
Vedolizumab: 85%
Placebo: 55
Vedolizumab: 55
71
  • *One-sided test based on binomial non-inferiority trials, significance level (α)=0.05, non-inferiority margin=0.15.

  • †Assuming 90% evaluability rate.

  • HBV, hepatitis B vaccine; OCV, oral cholera vaccine.