. 2013 Oct 20;33(8):1360–1375. doi: 10.1007/s10875-013-9949-3

Table 1.

Unsolicited adverse events occurring in more than 5 % of subjects in any group within 30 days after each dose (Total vaccinated cohort)

Preferred term	AS01_B			M72/Saline (40μg)			M72/AS01_E (10μg)			M72/AS02_D (10 μg)			M72/AS01_E (20μg)			M72/AS01_B (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