Determinant | Specification | No reaction % (n/N) | Risk ratio for presenting no reaction* (95% CI) or p value |
Maternal BCG scar status (RCTs IV–V)† | Mother has scar | 2 (39/1586) | Ref. |
Mother has no scar | 3 (26/958) | 1.09 (0.67 to 1.78) | |
Maternal ethnicity (% of cohort) (RCTs I–V) | Balanta (15%) | 3 (24/784) | 1.60 (0.75 to 3.42) |
Fula (20%) | 3 (32/1039) | 1.61 (0.78 to 3.35) | |
Mancanha (9%) | 2 (9/471) | Ref. | |
Mandinga (10%) | 3 (15/515) | 1.52 (0.67 to 3.45) | |
Manjaco (10%) | 4 (18/517) | 1.82 (0.83 to 4.02) | |
Pepel (17%) | 4 (38/1006) | 1.64 (0.78 to 3.45) | |
Other (19%) | 3 (28/892) | 1.98 (0.96 to 4.05) | |
Missing (13%) | 6 (44/744) | 2.92 (1.44 to 5.93) | |
Median maternal age in years (IQR) (RCTs I–III) | 24 (19–28) (reactors) versus 23 (19–29) (non-reactors) | NA | p=0.66‡ |
Median maternal age in years (IQR) (RCTs IV–V) | 27 (22–31) (reactors) versus 24 (20–28) (non-reactors) | NA | p=0.002‡ |
Median maternal age in years (IQR) (RCTs I–V) | 26 (21–30) (reactors) versus 23 (20–28) (non-reactors) | NA | p=0.001‡ |
Median maternal MUAC (IQR) (RCTs I–III) | 244 (226–260) (reactors) versus 238 (226–256) (non-reactors) | NA | p=0.84‡ |
Median maternal MUAC (IQR) (RCTs IV–V) | 270 (250–298) (reactors) versus 267 (249–294) (non-reactors) | NA | p=0.49‡ |
Median maternal MUAC (IQR) (RCTs I–V) | 260 (238–286) (reactors) versus 250 (232–280) (non-reactors) | NA | p<0.01‡ |
Place of inclusion (RCTs I–III)§ | HDSS health centre | 10 (21/213) | 2.43 (1.50 to 3.92) |
HNSM | 5 (91/1978) | Ref. | |
Weight group at inclusion (RCTs IV–V)¶ | Normal weight (≥2.5 kg) | 2 (75/3115) | Ref. |
Low weight (<2.5 kg) | 3 (21/706) | 1.33 (0.82 to 2.18) | |
Received neonatal vitamin A (RCT III)** | Yes | 7 (22/307) | 1.38 (0.73 to 2.61) |
No | 5 (15/289) | Ref. | |
Vaccinator (RCTs III–V) | 1 | 3 (106/3090) | 1.83 (1.25 to 2.67) |
2 | 2 (35/1877) | Ref. |
*Binomial regression, adjusted for RCT.
†Within a subgroup of 2544 infants included in RCTs IV–V, maternal BCG reaction assessments were performed at inclusion.
‡Kruskal-Wallis χ2 test with ties.
§Analysis comparing RCT I–III neonates since all infants in RCT IV–V were included at HNSM. At HNSM, vaccinator 1 and 2 performed all vaccinations while vaccinations at the HDSS health centres were performed by Bandim Health Project assistants that less frequently performed BCG vaccinations.
¶Analysis within studies IV–V which recruited both normal birth weight and low birth weight infants.
**RCT II was designed as a 2-by-2 factorial RCT with a subgroup of neonates randomised to receive either 25 000 International Units of NVAS or placebo, as well as either early-BCG or no-BCG.
BCG, Bacille Calmette-Guérin; MUAC, mid-upper-arm circumference; NA, not applicable; RCT, randomised controlled trial.