IRRs are presented for outcomes identified as safety signals in the phase 3 trial. Cerebral and severe malaria is shown for all cases and for the subset excluding cases that met the definition of suspected meningitis but for which meningitis status could not be determined (eg, due to a lumbar puncture not being done). Tracer conditions are those unlikely to be influenced by the RTS,S vaccine (admissions of any cause, excluding those with malaria, anaemia, or meningitis). IRR=incidence rate ratio. RTS,S=RTS,S/AS01Emalaria vaccine.