Phase 3 Tuberculosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The baby must be male or female and enrolled within the first seven days after birth.
• The mother must give written permission for her baby to take part, including allowing access to her own and her baby's medical records.
• The family must be willing and able to attend follow-up appointments and take part in all study activities.
• The baby must have been considered healthy during pregnancy and at birth, based on medical history and a physical check-up.
• The baby must have weighed at least 2,450 grams (about 5.4 pounds) at birth.
• The baby must have received an Apgar score (a quick health check done at birth) of 7 or higher at 5 minutes after birth.
• A recent HIV test result for the mother must be on record — if she does not have HIV, the test must have been done within 30 days before or 7 days after delivery; if she does have HIV, she must be on HIV treatment with a very low level of virus in her blood.
• The baby must have been born at or after 37 weeks of pregnancy (full term).
• The mother must not have taken part in any clinical trial in the three months before the baby's birth.
• The mother must never have taken part in a tuberculosis (TB) vaccine trial before.
• The baby must not be enrolled in any other clinical trials at the same time.

Who may not be able to join:

• The baby has already received a BCG vaccine (a vaccine commonly given at birth to protect against TB) before joining the trial.
• There were serious complications during or after pregnancy that could affect the baby's health.
• There is a skin problem, bruise, or birthmark at the spot on the body where the injection would be given.
• The mother's HIV test result is not available.
• The baby was exposed to HIV and their own HIV test result came back positive or is not yet available.
• The mother had tuberculosis (TB) during pregnancy.
• Anyone in the baby's home has TB and has not yet finished their TB treatment.
• The baby shows signs of a serious blood infection (neonatal sepsis).
• The baby was born with a severe physical abnormality.
• The baby has any signs of a serious illness or condition that, in the doctor's judgement, could affect how the trial results are measured (mild newborn jaundice on its own does not count as a reason to exclude the baby).

Important: Always verify eligibility with the trial site directly before applying.