RCT (years with inclusions) | BCG reaction size at 2 months of age | |||||
Small reaction % (n/N) | Medium reaction % (n/N) | Large reaction % (n/N) | Had BCG reaction % (n/N) | No BCG reaction % (n/N) | Total | |
RCTs I–III (2002–2013) | ||||||
BCG-Denmark | 3.9 (38/978) | 3.3 (18/552) | 2.4 (13/549) | 3.3 (69/2079) | 7.1 (8/112) | 3.5 (77/2191) |
RCT IV (2013–2017) | ||||||
BCG-Denmark (2013–2016) | 2.6 (13/500) | 2.0 (9/458) | 0.0 (0/509) | 1.5 (22/1467) | 0.0 (0/30) | 1.5 (22/1497) |
BCG-Japan (2016–2017) | 3.9 (4/102) | 1.0 (1/107) | 0.0 (0/142) | 1.4 (5/351) | 0.0 (0/11) | 1.4 (5/362) |
RCT V phase I* (2014–2016) | ||||||
BCG-Denmark | 1.6 (2/126) | 0.6 (1/168) | 0.4 (1/237) | 0.8 (4/531) | 0.0 (0/3) | 0.8 (4/534) |
BCG-Russia | 0.8 (2/240) | 0.0 (0/163) | 0.0 (0/85) | 0.4 (2/488) | 4.6 (1/22) | 0.6 (3/510) |
RCT V phase II* (2016–2017) | ||||||
BCG-Japan | 1.0 (1/103) | 0.0 (0/128) | 0.4 (1/227) | 0.4 (2/458) | 8.3 (1/12) | 0.6 (3/470) |
BCG-Russia | 2.4 (4/164) | 0.8 (1/134) | 0.0 (0/132) | 1.2 (5/430) | 0.0 (0/18) | 1.1 (5/448) |
Total (2002–2017) | ||||||
BCG-Denmark (RCTs I–V) | 3.3 (53/1604) | 2.4 (28/1178) | 1.1 (14/1295) | 2.3 (95/4077) | 5.5 (8/145) | 2.4 (103/4222) |
BCG-Japan (RCTs IV–V) | 2.4 (5/205) | 0.4 (1/225) | 0.3 (1/369) | 0.9 (7/809) | 4.4 (1/23) | 1.0 (8/832) |
BCG-Russia (RCT V) | 1.5 (6/404) | 0.3 (1/297) | 0.0 (0/217) | 0.8 (7/918) | 2.5 (1/40) | 0.8 (8/958) |
RCTs I–V, all strains | 2.9 (64/2213) | 1.8 (30/1710) | 0.8 (15/1881) | 1.9 (109/5804) | 4.8 (10/208) | 2.0 (119/6012) |
RCT IV and RCT V recruited neonates up to September and October 2017, respectively, and follow-up procedures for the last recruited infants were completed one year later.
*RCT V featured two phases: one randomising infants to BCG-Denmark versus BCG-Russia (phase I) and one randomising infants to BCG-Japan versus BCG-Russia (phase II).
BCG, Bacille Calmette-Guérin; RCT, randomised controlled trial; RR, risk ratio.