Table 1 Summary of safety endpoints for evaluation in studies EPI-MAL-002 and EPI-MAL-003

Adverse events of special interest*

Acute disseminated encephalomyelitis, encephalitis, Guillain-Barré syndrome, generalized convulsive seizure, hypotonic hypo-responsive episode, intussusception, hepatic insufficiency, renal insufficiency, juvenile chronic arthritis, Stevens Johnson syndrome and toxic epidermal necrolysis, Henoch Schonlein purpura, Kawasaki disease, diabetes mellitus type 1, thrombocytopenia and anaphylaxis

Meningitis*

Etiology confirmed meningitis, etiology confirmed, probable and clinically suspected meningitis, clinically suspected meningitis

Malaria

Any malaria, severe malaria, cerebral malaria

Deaths

Deaths all causes, death all causes: female/male

Other adverse events leading to hospitalization

Anemia, gastroenteritis, lower respiratory tract infection, sepsis, upper respiratory tract infection, skin infection, malnutrition, conjunctivitis, helminthic infection, urinary tract infection, bacterial infection, burn