Statistical analysis
swelling, toxicity, erythema, pain, tenderness
VACCINATION SITE REACTIONS, ERYTHEMA
StataIC 14.0 (Statacorp LP, College Station, TX, USA) was used for statistical analysis. The cumulative incidence of AEFI in the three-month post vaccination was calculated among participants who received either BCG or placebo, and who provided vaccine safety data. Local vaccination site reactions (pain, tenderness, erythema, swelling) were categorized according to the FDA toxicity grading scaleEthical approval was obtained from The Royal Children’s Hospital Human Research Ethics Committee (HREC 62586) with subsequent approvals from all participating sites. All research was performed in accordance with relevant guidelines and regulations. All participants provided signed informed consent prior to enrollment.