Table 3.

Adverse events following vaccinations 1, 2, and 3^a

Adverse event	No. (%) of patients with each AE in each group (n)
	1a (18)	1b (18)	2a (19)	2b (18)	3a (19)	3b (18)	4a (19)	4b (18)	5a (17)	5b (19)	6 (18)
AE reported days 1–14 after each vaccination
Systemic AE	6 (33.3)	6 (33.3)	4 (21.1)	4 (22.2)	5 (26.3)	6 (33.3)	8 (42.1)	5 (27.8)	6 (35.3)	6 (31.6)	7 (38.9)
AE with ≥10% incidence in any group
Diarrhea	0 (0.0)	1 (5.6)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (10.5)	0 (0.0)	0 (0.0)	2 (10.5)	0 (0.0)
Nausea	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (11.1)	1 (5.3)	1 (5.6)	0 (0.0)	1 (5.3)	0 (0.0)
Pancreatitis	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (11.1)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Vomiting	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (10.5)	1 (5.6)
Pyrexia	0 (0.0)	2 (11.1)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.3)	0 (0.0)	2 (11.8)	0 (0.0)	0 (0.0)
Headache	0 (0.0)	0 (0.0)	1 (5.3)	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.3)	1 (5.6)	0 (0.0)	0 (0.0)	2 (11.1)
Rhinorrhea	1 (5.6)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (10.5)	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.6)
AE reported days 1–5 after each vaccination
Injection site AE	5 (27.8)	6 (33.3)	1 (5.3)	4 (22.2)	8 (42.1)	7 (38.9)	9 (47.4)	6 (33.3)	7 (41.2)	9 (47.4)	2 (11.1)
AE with ≥10% incidence in any group
Erythema	3 (16.7)	2 (11.1)	0 (0.0)	1 (5.6)	3 (15.8)	3 (16.7)	4 (21.1)	0 (0.0)	2 (11.8)	2 (10.5)	2 (11.1)
Pain	5 (27.8)	5 (27.8)	1 (5.3)	3 (16.7)	8 (42.1)	4 (22.2)	8 (42.1)	5 (27.8)	5 (29.4)	9 (47.4)	2 (11.1)
Swelling	2 (11.1)	0 (0.0)	0 (0.0)	1 (5.6)	2 (10.5)	4 (22.2)	5 (26.3)	3 (16.7)	2 (11.8)	3 (15.8)	2 (11.1)
AE reported days 1–360
Systemic AE	7 (38.9)	7 (38.9)	7 (36.8)	8 (44.4)	6 (31.6)	8 (44.4)	11 (57.9)	7 (38.9)	8 (47.1)	10 (52.6)	10 (55.6)
Clinical AEb	9 (50.0)	10 (55.6)	8 (42.1)	10 (55.6)	10 (52.6)	13 (72.2)	12 (63.2)	11 (61.1)	11 (64.7)	12 (63.2)	10 (55.6)
Serious AE	2 (11.1)	3 (16.7)	2 (10.5)	5 (27.8)	0 (0.0)	5 (27.8)	4 (21.1)	2 (11.1)	2 (11.8)	5 (26.3)	3 (16.7)
Serious vaccine-related AEc	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Serious AE involving S. aureus infection	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.6)	0 (0.0)	2 (11.1)	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.3)	1 (5.6)
Discontinued study due to a vaccine-related AEc	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0(0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Death	1 (5.6)	2 (11.1)	0 (0.0)	2 (11.1)	0 (0.0)	0 (0.0)	4 (21.1)	1 (5.6)	1 (5.9)	3 (15.8)	2 (11.1)

^aAE, adverse event.

^bPatient-reported systemic or injection site AEs during the entire study period.

^cDetermined by the investigator to be related to the vaccine/placebo.