Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years

Inclusion Criteria: * Type 1 diabetic subjects diagnosed more than 3 months ago and less than 12 months ago at the time of randomization. * Male or female, age 8 - \<18 years at the time of the screening visit and \<18 at the time of randomization. * HIV antibody negative at the time of the screening visit. * Human chorionic gonadotropin (hCG) negative at the time of the screening visit, if female. * M. tuberculosis (TB) negative using a QuantiFERON-TB test prior to randomization, as judged by the Investigator. * Informed consent and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Legally Acceptable Representative (LAR) of the Subject must sign and date the Informed Consent Form (according to local requirements). The child must sign and date the Child Assent Form or provide oral assent, if required according to local requirements. * Previously diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) prior to study enrollment by WHO/ADA diagnostic criteria for glucose levels (FPG = 7.0 mmol/L \[126 mg/dL\]) or plasma glucose levels 2-hours after 75-gm oral glucose load of = 11.1 mmol/L (200 mg/dL) or a casual plasma glucose \>200 mg/dL with symptoms. * Presence of one or more of the following prior to randomization: antibodies…