Table 2:

Adverse events occurring in ≥ 5% of the study population

AE by system organ class preferred term*	Vaccine plus OPT-821		OPT-821
	Grade 1–2	Grade 3	Grade 1–2	Grade 3
Gastrointestinal disorders
Abdominal pain	4 (5.9)	0 (0.0)	0 (0.0)	0 (0.0)
Diarrhea	2 (2.9)	0 (0.0)	9 (13.2)	0 (0.0)
Nausea	5 (7.4)	1 (1.5)	6 (8.8)	0 (0.0)
General disorders and administration site conditions
Fatigue	30 (44.1)	0 (0.0)	13 (19.1)	0 (0.0)
Influenza like illness	10 (14.7)	0 (0.0)	3 (4.4)	0 (0.0)
Injection site erythema	12 (17.6)	0 (0.0)	5 (7.4)	0 (0.0)
Injection site oedema	8 (11.8)	0 (0.0)	1 (1.5)	0 (0.0)
Injection site pain	8 (11.8)	0 (0.0)	8 (11.8)	0 (0.0)
Injection site reaction	59 (86.8)	2 (2.9)	47 (69.1)	0 (0.0)
Malaise	5 (7.4)	0 (0.0)	3 (4.4)	0 (0.0)
Pain	5 (7.4)	0 (0.0)	3 (4.4)	0 (0.0)
Pyrexia	18 (26.5)	1 (1.5)	2 (2.9)	0 (0.0)
Infections and infestations
Upper respiratory tract infection	8 (11.8)	0 (0.0)	7 (10.3)	0 (0.0)
Musculoskeletal and connective tissue disorders
Arthralgia	4 (5.9)	0 (0.0)	5 (7.4)	0 (0.0)
Myalgia	4 (5.9)	0 (0.0)	4 (5.9)	0 (0.0)
Pain in extremity	4 (5.9)	0 (0.0)	6 (8.8)	0 (0.0)
Nervous system disorders
Headache	6 (8.8)	0 (0.0)	6 (8.8)	1 (1.5)
Psychiatric disorders
Anxiety	6 (8.8)	0 (0.0)	6 (8.8)	0 (0.0)
Respiratory, thoracic and mediastinal disorders
Cough	8 (11.8)	0 (0.0)	3 (4.4)	0 (0.0)
Skin and subcutaneous tissue disorders
Erythema	4 (5.9)	1 (1.5)	0 (0.0)	0 (0.0)
Rash	5 (7.4)	0 (0.0)	0 (0.0)	0 (0.0)

^*All numbers represent number of patients (%)