Table 1.
Neonatal mortality rates and HR comparing early BCG with delayed BCG, by sex, trial and season (November–January vs February–October)
| Trial II | Trial III | Trial I+II+III | ||||||||
| MR (deaths/100 pyrs) | HR (95% CI) | MR (deaths/100 pyrs) | HR (95% CI) | MR (deaths/100 pyrs) | HR (95% CI) | |||||
| Early BCG | Delayed BCG | BCG early /delayed | Early BCG | Delayed BCG | BCG early /delayed | Early BCG | Delayed BCG | BCG early /delayed | ||
| ALL | November–January | 16.6 (4/24.2) | 84.3 (20/23.7) | 0.19 (0.07 to 0.57) | 16.1 (6/37.2) | 62.9 (23/36.6) | 0.25 (0.10 to 0.63) | 16.1 (10/62.0) | 72.2 (44/60.9) | 0.22 (0.11 to 0.45) |
| February–October | 43.6 (23/52.7) | 53.8 (28/52.1) | 0.81 (0.46 to 1.42) | 38.1 (38/99.7) | 39.5 (39/98.7) | 0.97 (0.61 to 1.53) | 40.7 (63/154.8) | 47.0 (72/153.2) | 0.86 (0.61 to 1.21) | |
| # | 0.02 | 0.01 | 0.001 | |||||||
| BOYS | November–January | 29.2 (3/10.3) | 129.6 (13/10.0) | 0.22 (0.06 to 0.78) | 16.0 (2/12.5) | 91.8 (11/12.0) | 0.17 (0.04 to 0.78) | 21.6 (5/23.2) | 107.4 (24/22.4) | 0.20 (0.08 to 0.53) |
| February–October | 59.2 (13/22.0) | 63.5 (14/22.0) | 0.94 (0.44 to 1.99) | 51.6 (16/31.0) | 55.6 (17/30.6) | 0.94 (0.48 to 1.86) | 55.3 (30/54.2) | 67.5 (36/53.4) | 0.81 (0.49 to 1.32) | |
| # | 0.05 | 0.04 | 0.01 | |||||||
| GIRLS | November–January | 7.2 (1/13.9) | 51.2 (7/13.7) | 0.14 (0.02 to 1.14) | 16.2 (4/24.7) | 48.7 (12/24.6) | 0.34 (0.11 to 1.04) | 12.9 (5/38.9) | 51.9 (20/38.6) | 0.25 (0.09 to 0.66) |
| February–Oct | 32.5 (10/30.7) | 46.6 (14/30.0) | 0.70 (0.31 to 1.58) | 32.0 (22/68.6) | 32.3 (22/68.2) | 0.99 (0.53 to 1.83) | 32.8 (33/100.6) | 36.1 (36/99.8) | 0.89 (0.55 to 1.45) | |
| # | 0.16 | 0.10 | 0.02 | |||||||
HR comparing early BCG with delayed BCG. # indicates test of interaction between BCG and season.
MR, mortality rate (neonatal deaths per 100 person-years (pyrs)).