Table 2.

Frequency of treatment-associated adverse events in the phase 2a and 2b studies

		FINLAY-FR-1A vaccine group (n=364)*	Vaccine excipient group (n=86)
Subjects with TAAEs		117 (32%)	18 (21%)
Subjects with serious TAAEs		0	0
Subjects with severe TAAEs		1 (<1%)*	0
Solicited local TAAEs
	Site pain	105 (29%)	13 (15%)
	Swelling	16 (4%)	4 (5%)
	Local heat	14 (4%)	0
	Induration	11 (3%)	1 (1%)
	Redness	8 (2%)	0
Solicited systemic TAAEs
	General malaise	24 (7%)	7 (8%)
	Headache	15 (4%)	1 (1%)
	Somnolence	8 (2%)	1 (1%)
	Fever	2 (1%)	1 (1%)
	Limitation of activity	0	1 (1%)
Unsolicited systemic TAAEs
	Dizziness	1 (<1%)	0
	Diarrhoea	1 (<1%)	0
	Asthenia	0	1 (1%)
	Nasal discharge	1 (<1%)	1 (1%)
	Fatigue	1 (<1%)	0
	Cough	1 (<1%)	0
	Dyspnoea	1 (<1%)	0
	Bilateral conjunctival injection	1 (<1%)	0
	Chills	1 (<1%)	0
Number of TAAEs per subject
	Mean (SD)	0·6 (1·0)	0·4 (0·8)
	Median (IQR)	0	0
	Range	0–5	0–4

Data are n (%) unless stated otherwise. TAAE=treatment-associated adverse event.

^*n=364 comprises 20 participants from the phase 2a study and 344 participants from the phase 2b study.

^*1 participant experienced headache that impeded activities.