Table 3 Systemic and local solicited adverse events throughout the study
From: Whole sporozoite immunization with Plasmodium falciparum strain NF135 in a randomized trial
Low dose (n = 10) | High dose (n = 30) | |||||
|---|---|---|---|---|---|---|
% Of subjects | Mean number of episodes/subject | Median duration in days (range) | % Of subjects | Mean number of episodes/subject | Median duration in days (range) | |
Systemic solicited | ||||||
Headache | 100 | 1.7 | 2.33 (0.17–4.79) | 90 | 1.6 | 1.19 (0.01–5.00) |
Fever | 60 | 0.8 | 0.24 (0.02–1.46) | 87 | 1.7 | 0.31 (0.02–2.93) |
Nausea | 80 | 0.8 | 1.70 (0.04–4.48) | 43 | 0.6 | 0.58 (0.08–5.96) |
Myalgia | 50 | 0.7 | 2.54 (0.13–3.98) | 50 | 0.6 | 1.5 (0.38–7.00) |
Malaise | 40 | 0.4 | 1.79 (0.65–4.46) | 63 | 0.9 | 0.96 (0.08–3.96) |
Fatigue | 20 | 0.3 | 3 (2.79–3.21) | 27 | 0.4 | 1.29 (0.15–5.21) |
Chills | NA | NA | NA | 30 | 0.3 | 0.15 (0.04–1.75) |
Sweats | NA | NA | NA | 23 | 0.3 | 0.43 (0.29–4.06) |
Dizziness | 20 | 0.3 | 0.04 (0.02–2.71) | 23 | 0.2 | 1.02 (0.13–1.90) |
Abdominal pain | NA | NA | NA | 10 | 0.1 | 0.87 (0.08–1.42) |
Vomiting | 10 | 0.1 | 0.1 | 3 | 0.0 | 1.35 |
Diarrhea | NA | NA | NA | 3 | 0.0 | 0.29 |
Chest paina | NA | NA | NA | 3 | 0.0 | 5.6 |
Local solicitedb | ||||||
Pruritus | 20 | 0.2 | 1.1 (0.86–1.33) | 7 | 0.1 | 0.63 |