Table 3.

Number of unsolicited AEs in recipients of NS and PfSPZ Vaccine

Unsolicited AEs (MedRA term)	NS N (%)*	PfSPZ Vaccine N (%)*
Dental and periodontal infections	1 (6.3%)	3 (18.8%)
Ear and labyrinth disorders	0 (0.0%)	1 (6.3%)
Gastrointestinal disorders	0 (0.0%)	1 (6.3%)
General disorders	3 (18.8%)	1 (6.3%)
Infections and infestations	6 (37.5%)	8 (50.0%)
Injury and procedural complications	2 (12.5%)	0 (0.0%)
Musculoskeletal and connective tissue disorders	3 (18.8%)	1 (6.3%)
Nervous system disorders	0 (0.0%)	1 (6.3%)
Skin and subcutaneous tissue disorders	1 (6.3%)	0 (0.0%)
Total number of unsolicited AEs	16	16

AE = adverse event; NS = normal saline; PfSPZ = Plasmodium falciparum sporozoites. There were no significant differences in the incidence of unsolicited AEs between recipients of NS and PfSPZ Vaccine. The P values were calculated on a per volunteer basis (e.g. 3/20 vs. 1/10 for dental and periodontal infections) in a two-sided Fisher’s exact test. All P values were ≥ 0.1.

^*The numbers in brackets are calculated as the proportion of the total unsolicited AEs reported.