Determining causes of mortality in children enrolled in a vaccine field trial in a rural area in the Western Cape Province of South Africa.

Aim: A mortality surveillance system was developed to identify and document causes of death among children enrolled in a tuberculosis vaccine field trial in South Africa. The aims of this study were to describe causes of mortality in children enrolled in a phase IV trial comparing intradermal with percutaneous administration of Bacille Calmette Guerin, and to compare causes of mortality recorded on death certificates with those obtained by clinical record review combined with verbal autopsies (CR/VA).

Methods: For children who died, certified causes of death were compared with those determined by CR/VA.