Table 2.

Summary of safety outcomes.

Overall Summary of Adverse Events
	PfSPZ-CVac (N = 31)	Control (N = 31)
Participantsa with:	n (%)	n (%)
At least one local solicited adverse event within 12 days of vaccination	15 (48)	9 (19)
At least one systemic solicited adverse event within 12 days of vaccination	6 (19)	7 (23)
At least one unsolicited adverse event during the study period	25 (81)	28 (90)
At least one related unsolicited adverse event within 12 days of vaccination	2 (6)	2 (6)
Mild (Grade 1)	2 (6)	2 (6)
Moderate (Grade 2)	0	0
Severe (Grade 3)	0	0
At least one severe (Grade 3) unsolicited adverse event during the study period	1 (3)	0
Related	0	0
Unrelated	1 (3)	0
At least one serious adverse event during the study period	1b (3)	0
At least one related, serious adverse event during the study period	0	0
At least one adverse event during the study period leading to early termination	1b (3)	0
Solicited events within 12 days of vaccination
	PfSPZ-CVac (N = 31)	Control (N = 31)
Symptoms/signs	n (%)	n (%)
Any Symptom/sign	18 (58·1)	14 (45·2)
Any Systemic Symptom/sign	6 (19·4)	7 (22·6)
Any Local Symptom/sign	15 (48·4)	9 (29·0)
Arthralgia/Joint Pain	1 (3.2)	0
Chills	0	1 (3·2)
Feverishness	1 (3·2)	1 (3·2)
Headache	3 (9·7)	3 (9·7)
Malaise	2 (6·5)	3 (9·7)
Myalgia/Body Aches	0	0
Nausea	0	1 (3·2)
Fever	0	1 (3·2)
Ecchymosis/Bruising Measurement	0	0
Erythema/Redness Measurement	0	0
Induration/Swelling Measurement	1 (3·2)	0
Induration/Swelling Severity	1 (3·3)	0
Pain at Injection Site	15 (48·4)	9 (29·0)
Tenderness at Injection Site	0	0

N  =  Number of participants in the Safety Population; n = Number of participants in the Safety population experiencing the symptom after at least one dose.

^aParticipants are counted once for each category regardless of the number of events.

^bRefers to a single adverse event occurring in one participant.