Table 1 Assumptions used for sample size calculation for the first 14Â weeks of life
Assumption | Estimated level |
|---|---|
Two-sided significance level | 0.05 |
Ratio of sample size early/late BCG vaccination | 1 |
Percent of vaccinated at 14Â weeks of age with severe illness | 15 |
Percent of vaccinated at birth with severe illness | 10 |
Risk ratio: | 0.7 |
Risk difference | 5 |
Total sample size (i.e., in both trial arms) | 1914 |