Table 2.

Adverse events within 28 days following the administration of a vaccine dose.

	Phase 1 trial (0/14)			Phase 2 trial (0/14)			Phase 2 trial (0/28)
Items	5 μg group (N = 24)	10 μg group (N = 24)	Placebo group (N = 12)	5 μg group (N = 100)	10 μg group (N = 100)	Placebo group (N = 50)	5 μg group (N = 100)	10 μg group (N = 100)	Placebo group (N = 50)
Any AE	13 (54)	11 (46)	7 (58)	16 (16)	19 (19)	9 (18)	25 (25)	26 (26)	11 (22)
Grade 3 or more	0	0	0	0	0	0	0	0	0
Vaccination-related AE	10 (42)	6 (25)	6 (50)	13 (13)	17 (17)	6 (12)	19 (19)	24 (24)	9 (18)
Solicited injection-site AE	4 (17)	4 (17)	2 (17)	11 (11)	8 (8)	4 (8)	16 (16)	18 (18)	7 (14)
Induration	1 (4)	0	0	2 (2)	0	0	0	3 (3)	0
Swelling	0	0	0	0	0	0	0	2 (2)	0
Erythema	2 (8)	0	0	1 (1)	0	0	1 (1)	5 (5)	0
Pain	3 (13)	4 (17)	2 (17)	8 (8)	8 (8)	4 (8)	15 (15)	12 (12)	7 (14)
Pruritus	0	0	0	2 (2)	1 (1)	1 (2)	1 (1)	2 (2)	0
Solicited systemic AE	2 (8)	1 (4)	1 (8)	6 (6)	11 (11)	4 (8)	6 (6)	10 (10)	2 (4)
Fever	0	0	0	1 (1)	2 (2)	1 (2)	1 (1)	1 (1)	1 (2)
Diarrhea	0	0	0	0	2 (2)	1 (2)	1 (1)	2 (2)	0
Inappetence	0	0	0	1 (1)	1 (1)	0	0	0	0
Vomiting	0	0	0	0	1 (1)	0	0	0	0
Nausea	0	0	0	0	0	0	0	1 (1)	0
Myalgia	1 (4)	0	0	1 (1)	1 (1)	1 (2)	1 (1)	0	0
Headache	0	0	0	2 (2)	6 (6)	0	2 (2)	0	1 (2)
Cough	0	0	1 (8)	0	3 (3)	0	1 (1)	3 (3)	0
Dyspnea	0	0	0	0	1 (1)	1 (2)	0	0	0
Skin or mucosa abnormality	0	0	0	0	1 (1)	0	0	0	0
Fatigue	2 (8)	1 (4)	1 (8)	2 (2)	6 (6)	0	2 (2)	3 (3)	1 (2)
Unsolicited AE	7 (29)	3 (13)	4 (33)	0	0	0	0	0	0

Data are n (%) of participants experiencing the relevant adverse events. 0/14 or 0/28: Participants received two doses on Days 0 and 14 or Days 0 and 28, respectively; AE: Adverse effect.