TABLE 1.

Incidence of solicited adverse events reported during the 7-day follow-up period after all vaccinations of the primary vaccination phase

AE	% AEs reported (95% CI) for each vaccine group
	Mtb72F (10 μg)/AS02A (na = 30)	Mtb72F (40 μg)/AS02A (n = 29)	Mtb72F (10 μg)/saline (n = 29)	Mtb72F (40 μg)/saline (n = 30)	AS02A (n = 30)
Local AEs
Pain
All	90.0 (73.5-97.9)	89.7 (72.6-97.8)	17.2 (5.8-35.8)	30.0 (14.7-49.4)	100.0 (88.4-100.0)
Grade 3	10.0 (2.1-26.5)	3.4 (0.1-17.8)	0.0 (0.0-11.9)	0.0 (0.0-11.6)	20.0 (7.7-38.6)
Redness
All	36.7 (19.9-56.1)	6.9 (0.8-22.8)	0.0 (0.1-17.2)	3.3 (0.0-11.9)	23.3 (9.9-42.3)
Grade 3	16.7 (5.6-34.7)	0.0 (0.0-11.9)	0.0 (0.0-11.9)	0.0 (0.0-11.6)	16.7 (5.6-34.7)
Swelling
All	53.3 (34.3-71.7)	31.0 (15.3-50.8)	3.4 (0.8-22.1)	6.7 (0.1-17.8)	60.0 (40.6-77.3)
Grade 3	26.7 (12.3-45.9)	10.3 (2.2-27.4)	0.0 (0.0-11.9)	0.0 (0.0-11.6)	46.7 (28.3-65.7)
General AEs
Fatigue
All	50.0 (31.3-68.7)	51.7 (32.5-70.6)	37.9 (20.7-57.7)	26.7 (12.3-45.9)	20.0 (7.7-38.6)
Grade 3	10.0 (2.1-26.5)	6.9 (0.8-22.8)	0.0 (0.0-11.9)	0.0 (0.0-11.6)	0.0 (0.0-11.6)
Feverb
All	13.3 (3.8-30.7)	10.3 (2.2-27.4)	3.4 (0.1-17.8)	0.0 (0.0-11.6)	3.3 (0.1-17.2)
Grade 3	0.0 (0.0-11.6)	0.0 (0.0-11.9)	0.0 (0.0-11.9)	0.0 (0.0-11.6)	0.0 (0.0-11.6)
Gastrointestinalc
All	16.7 (5.6-34.7)	17.2 (5.8-35.8)	20.7 (8.0-39.7)	16.7 (5.6-34.7)	20.0 (7.7-38.6)
Grade 3	0.0 (0.0-11.6)	6.9 (0.8-22.8)	3.4 (0.1-17.8)	0.0 (0.0-11.6)	3.3 (0.1-17.2)
Headache
All	33.3 (17.3-52.8)	34.5 (17.9-54.3)	20.7 (8.0-39.7)	26.7 (12.3-45.9)	36.7 (19.9-56.1)
Grade 3	0.0 (0.0-11.6)	0.0 (0.0-11.9)	0.0 (0.0-11.9)	3.3 (0.1-17.2)	0.0 (0.0-11.6)

^an, total number of doses administered.

^bFever was defined as an axillary temperature of ≥37.5°C (99.5°F).

^cGastrointestinal AEs were nausea, vomiting, diarrhea, and/or abdominal pain.