Table 2.

Subjects with reactogenicity and adverse events following vaccination

	Post dose 1 n; % (95% CI)		Post dose 2 n; % (95% CI)
Outcomes	Vaccine N=28	Placebo N=10	Vaccine N=28	Placebo N=10
Within 2 hours post-vaccination
Any adverse reaction	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)
Within 7 d post-vaccination
Solicited reactions
Local reaction	4; 14.3 (5.7; 31.5)	2; 20.0 (5.7; 51.0)	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)
Systemic reaction	13; 46.4 (29.5; 64.2)	4; 40.0 (16.8; 68.7)	9; 32.1 (17.9; 50.7)	2; 20.0 (5.7; 51.0)
Any	13; 46.4 (29.5; 64.2)	5; 50.0 (23.7; 76.3)	9; 32.1 (17.9; 50.7)	2; 20.0 (5.7; 51.0)
Solicited local reactions
Nose dryness	4; 14.3 (5.7; 31.5)	2; 20.0 (5.7; 51.0)	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)
Solicited systemic reactions
Fatigue/malaise	1; 3.6 (0.6; 17.7)	0; 0.0 (0.0; 27.8)	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)
Headache	2; 7.1 (2.0; 22.6)	0; 0.0 (0.0; 27.8)	2; 7.1 (2.0; 22.6)	1; 10.0 (1.8; 40.4)
Sore throat	3; 10.7 (3.7; 27.2)	4; 40.0 (16.8; 68.7)	5; 17.9 (7.9; 35.6)	1; 10.0 (1.8; 40.4)
Vomiting	1; 3.6 (0.6; 17.7)	0; 0.0 (0.0; 27.8)	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)
Temperature	12; 42.9 (26.5; 60.9)	1; 10.0 (1.8; 40.4)	4; 14.3 (5.7; 31.5)	0; 0.0 (0.0; 27.8)
Adverse events
Worst grade – mild	22; 78.6 (60.5; 89.8)	9; 90.0 (59.6; 98.2)	25; 89.3 (72.8; 96.3)	7; 70.0 (39.7; 89.2)
Worst grade – moderate	1; 3.6 (0.6; 17.7)	1; 10.0 (1.8; 40.4)	3; 10.7 (3.7; 27.2)	0; 0.0 (0.0; 27.8)
Worst grade – severe	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)
Any event	22; 78.6 (60.5; 89.8)	9; 90.0 (59.6; 98.2)	25; 89.3 (72.8; 96.3)	7; 70.0 (39.7; 89.2)
Any treatment–related event	16; 57.1 (39.1; 73.5)	5; 50.0 (23.7; 76.3)	19; 67.9 (49.3; 82.1)	4; 40.0 (16.8; 68.7)
Any serious adverse event	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)	0; 0.0 (0.0; 12.1)	0; 0.0 (0.0; 27.8)

CI, 95% confidence interval as calculated by Wilson test.