Table 1.
Preferred term | AS01B | M72/Saline (40μg) | M72/AS01E (10μg) | M72/AS02D (10 μg) | M72/AS01E (20μg) | M72/AS01B (40μg) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N = 10 | N = 10 | N = 40 | N = 40 | N = 40 | N = 40 | |||||||||||||
n | % [95 % CI] | n | % [95 % CI] | n | % [95 % CI] | n | % [95 % CI] | n | % [95 % CI] | n | % [95 % CI] | |||||||
≥one symptom | 7 | 70.0 | [34.8–93.3] | 9 | 90.0 | [55.5–99.7] | 29 | 72.5 | [56.1–85.4] | 33 | 82.5 | [67.2–92.7] | 33 | 82.5 | [67.2–92.7] | 27 | 67.5 | [50.9–81.4] |
Chills | 0 | 0 | [0–30.8] | 0 | 0 | [0–30.8] | 3 | 7.5 | [1.6–20.4] | 1 | 2.5 | [0.1–13.2] | 1 | 2.5 | [0.1–13.2] | 1 | 2.5 | [0.1–13.2] |
Contusion | 0 | 0 | [0–30.8] | 1 | 10.0 | [0.3–44.5] | 1 | 2.5 | [0.1–13.2] | 2 | 5.0 | [0.6–16.9] | 0 | 0 | [0–8.8] | 0 | 0 | [0–8.8] |
Cough | 0 | 0 | [0–30.8] | 4 | 40.0 | [12.2–73.8] | 3 | 7.5 | [1.6–20.4] | 6 | 15.0 | [5.7–29.8] | 13 | 32.5 | [18.6–49.1] | 11 | 27.5 | [14.6–43.9] |
Diarrhoea | 1 | 10.0 | [0.3–44.5] | 0 | 0 | [0–30.8] | 0 | 0 | [0–8.8] | 1 | 2.5 | [0.1–13.2] | 3 | 7.5 | [1.6–20.4] | 1 | 2.5 | [0.1–13.2] |
Dizziness | 2 | 20.0 | [2.5–55.6] | 1 | 10.0 | [0.3–44.5] | 1 | 2.5 | [0.1–13.2] | 5 | 12.5 | [4.2–26.8] | 4 | 10.0 | [2.8–23.7] | 2 | 5.0 | [0.6–16.9] |
Dyspnoea | 0 | 0 | [0–30.8] | 2 | 20.0 | [2.5–55.6] | 1 | 2.5 | [0.1–13.2] | 0 | 0 | [0–8.8] | 1 | 2.5 | [0.1–13.2] | 2 | 5.0 | [0.6–16.9] |
Feeling hot | 0 | 0 | [0–30.8] | 0 | 0 | [0–30.8] | 0 | 0 | [0–8.8] | 1 | 2.5 | [0.1–13.2] | 4 | 10.0 | [2.8–23.7] | 1 | 2.5 | [0.1–13.2] |
Headache | 2 | 20.0 | [2.5–55.6] | 3 | 30.0 | [6.7–65.2] | 5 | 12.5 | [4.2–26.8] | 7 | 17.5 | [7.3–32.8] | 11 | 27.5 | [14.6–43.9] | 7 | 17.5 | [7.3–32.8] |
Malaise | 0 | 0 | [0–30.8] | 3 | 30.0 | [6.7–65.2] | 0 | 0 | [0–8.8] | 0 | 0 | [0–8.8] | 2 | 5.0 | [0.6–16.9] | 2 | 5.0 | [0.6–16.9] |
Myalgia | 2 | 20.0 | [2.5–55.6] | 2 | 20.0 | [2.5–55.6] | 1 | 2.5 | [0.1–13.2] | 0 | 0 | [0–8.8] | 0 | 0 | [0–8.8] | 0 | 0 | [0–8.8] |
Nasopharyngitis | 4 | 40.0 | [12.2–73.8] | 5 | 50.0 | [18.7–81.3] | 15 | 37.5 | [22.7–54.2] | 10 | 25.0 | [12.7–41.2] | 18 | 45.0 | [29.3–61.5] | 16 | 40.0 | [24.9–56.7] |
Oropharyngeal pain | 0 | 0 | [0–30.8] | 0 | 0 | [0–30.8] | 1 | 2.5 | [0.1–13.2] | 4 | 10.0 | [2.8–23.7] | 1 | 2.5 | [0.1–13.2] | 3 | 7.5 | [1.6–20.4] |
Productive cough | 0 | 0 | [0–30.8] | 0 | 0 | [0–30.8] | 3 | 7.5 | [1.6–20.4] | 2 | 5.0 | [0.6–16.9] | 2 | 5.0 | [0.6–16.9] | 3 | 7.5 | [1.6–20.4] |
Pyrexia | 1 | 10.0 | [0.3–44.5] | 3 | 30.0 | [6.7–65.2] | 4 | 10.0 | [2.8–23.7] | 4 | 10.0 | [2.8–23.7] | 5 | 12.5 | [4.2–26.8] | 3 | 7.5 | [1.6–20.4] |
Throat irritation | 0 | 0 | [0–30.8] | 1 | 10.0 | [0.3–44.5] | 2 | 5.0 | [0.6–16.9] | 3 | 7.5 | [1.6–20.4] | 3 | 7.5 | [1.6–20.4] | 2 | 5.0 | [0.6–16.9] |
Toothache | 1 | 10.0 | [0.3–44.5] | 0 | 0 | [0–30.8] | 1 | 2.5 | [0.1–13.2] | 0 | 0 | [0–8.8] | 3 | 7.5 | [1.6–20.4] | 1 | 2.5 | [0.1–13.2] |
N number of subjects with at least one administered dose; n/%, number/percentage of subjects reporting at least once the symptom; 95 % CI, 95 % confidence interval