Table 1

Neonatal mortality rates and HR comparing early BCG with delayed BCG, by sex, trial and season (November–January vs February–October)

Trial IITrial IIITrial 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 BCGDelayed BCGBCG early /delayedEarly BCGDelayed BCGBCG early /delayedEarly BCGDelayed BCGBCG early /delayed
ALLNovember–January16.6 (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–October43.6 (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)
#0.020.010.001
BOYSNovember–January29.2 (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–October59.2 (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)
#0.050.040.01
GIRLSNovember–January7.2 (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–Oct32.5 (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)
#0.160.100.02
  • 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)).