Table 1. Serious adverse events experienced by all subjects (months 0–24, all randomized participants).

Description	FMP2.1/AS02A group (n = 199)	Control group (n = 201)	Outcome
Paralytic ileus	1 (0.5% [0.0–3.1])	0 (0.0% [0.0–2.3])	Resolved
Pyrexia	1 (0.5% [0.0–3.1])	0 (0.0% [0.0–2.3])	Resolved
Severe malaria	2 (1.0% [0.0–3.8])	0 (0.0% [0.0–2.3])	Resolved
Cerebral malaria	1 (0.5% [0.0–3.1])	0 (0.0% [0.0–2.3])	Death
Dehydration	1 (0.5% [0.0–3.1])	0 (0.0% [0.0–2.3])	Resolved
Febrile convulsion	1 (0.5% [0.0–3.1])	1 (0.5% [0.0–3.1])	Resolved
Status epilepticus	0 (0.0% [0.0–2.3])	1 (0.5% [0.0–3.1])	Death
Respiratory distress	1 (0.5% [0.0–3.1])	0 (0.0% [0.0–2.3])	Resolved
TOTAL	8 (4.0% [1.9–7.9])	2 (1.0% [0.0–3.8])

Data are reported as: Number of participants with a serious adverse event (% [95% confidence interval]) among participants given at least one dose of vaccine.