ITT analysis population | PP analysis population | |||||
---|---|---|---|---|---|---|
Prophylaxis group | Control group | Efficacy* | Prophylaxis group | Control group | Efficacy* | |
% (n/N) | % (n/N) | % (95% CI) | % (n/N) | % (n/N) | % (95% CI) | |
Fever ≥38°C | Fever ≥38°C | |||||
Infant series | 43.0 (43/100) | 75.4 (95/126) | 43.0 (17.4, 61.2) | 36.3 (29/80) | 75.9 (82/108) | 52.3 (26.3, 69.9) |
Toddler dose | 53.7 (58/108) | 63.9 (76/119) | 15.9 (−19.9, 41.3) | 51.6 (49/95) | 61.5 (67/109) | 16.1 (−23.1, 43.2) |
Fever >39°C | Fever >39°C | |||||
Dose 1 | 0 | 4.0 (5/124) | 100.0 (−17.7, 100) | 0 | 4.6 (5/109) | 100.0 (−22.6, 100.0) |
Dose 2 | 0 | 1.8 (2/112) | 100.0 (NA) | 0 | 2.0 (2/100) | 100.0 (NA) |
Dose 3 | 1.0 (1/102) | 1.9 (2/103) | 49.5 (NA) | 1.1 (1/87) | 1.1 (1/91) | −4.6 (NA) |
Toddler dose | 4.6 (4/87) | 13.1 (13/99) | 65.0 (−13.3, 91.7) | 2.6 (2/78) | 12.2 (11/90) | 79.0 (3.9, 97.7) |