Table 3.

Adverse events and reactions in the phase 2 trial

	Two-dose schedule			Three-dose schedule			p value
	Placebo (n=150)	25 μg dose (n=150)	50 μg dose (n=150)	Placebo (n=150)	25 μg dose (n=150)	50 μg dose (n=150)
Overall adverse events within 30 days
Any	37 (25%)	43 (29%)	50 (33%)	47 (31%)	72 (48%)	65 (43%)	<0·0001
Grade ≥3	0	4 (3%)	2 (1%)	2 (1%)	4 (3%)	6 (4%)	0·1871
Solicited adverse reactions within 7 days
Any	16 (11%)	27 (18%)	32 (21%)	19 (13%)	55 (37%)	42 (28%)	<0·0001
Grade ≥3	0	2 (1%)	1 (1%)	1 (1%)	2 (1%)	5 (3%)	0·1460
Solicited systemic adverse reactions
Any	8 (5%)	15 (10%)	16 (11%)	16 (11%)	15 (10%)	13 (9%)	0·5890
Grade ≥3	0	2 (1%)	0	1 (1%)	0	0	0·2189
Fever	6 (4%)	8 (5%)	10 (7%)	12 (8%)	12 (8%)	11 (7%)	0·6787
Grade ≥3 fever	0	1 (1%)	0	0	0	0	0·4152
Headache	1 (1%)	3 (2%)	1 (1%)	0	3 (2%)	0	0·2160
Grade ≥3 headache	0	1 (1%)	0	0	0	0	0·4152
Fatigue	0	4 (3%)	3 (2%)	4 (3%)	0	0	0·0422
Cough	1 (1%)	3 (2%)	3 (2%)	3 (2%)	1 (1%)	0	0·4310
Grade ≥3 cough	0	0	0	1 (1%)	0	0	0·4152
Nausea	1 (1%)	1 (1%)	0	1 (1%)	0	1 (1%)	0·8479
Muscle pain	0	1 (1%)	0	0	1 (1%)	0	0·5481
Solicited local adverse reactions
Any	9 (6%)	17 (11%)	19 (13%)	6 (4%)	45 (30%)	35 (23%)	<0·0001
Grade ≥3	0	0	1 (1%)	0	2 (1%)	5 (3%)	0·0121
Injection-site pain	6 (4%)	5 (3%)	7 (5%)	4 (3%)	18 (12%)	18 (12%)	0·0003
Grade ≥3 injection-site pain	0	0	0	0	1 (1%)	0	0·4152
Swelling	2 (1%)	6 (4%)	9 (6%)	2 (1%)	21 (14%)	20 (13%)	<0·0001
Grade ≥3 swelling	0	0	0	0	0	3 (2%)	0·0102
Induration	1 (1%)	4 (3%)	8 (5%)	0	14 (9%)	11 (7%)	<0·0001
Grade ≥3 induration	0	0	0	0	0	1 (1%)	0·4152
Redness	2 (1%)	12 (8%)	12 (8%)	1 (1%)	24 (16%)	21 (14%)	<0·001
Grade ≥3 redness	0	0	1 (1%)	0	1 (1%)	4 (3%)	0·0337
Rash	0	3 (2%)	4 (3%)	0	2 (1%)	1 (1%)	0·1514
Grade ≥3 rash	0	0	0	0	0	1 (1%)	0·4152
Itch	0	9 (6%)	13 (9%)	0	28 (19%)	26 (17%)	<0·0001
Unsolicited adverse reactions
Any	6 (4%)	5 (3%)	4 (3%)	8 (5%)	7 (5%)	4 (3%)	0·7847

Data are n (%). p values are calculated with Fisher's exact test.