Table 3.

Safety of phase 2 trial: local and systemic AEs observed within 7 days after the first or the second vaccinations.

	AEs after the first vaccination		AEs after the second vaccination
	Vaccine (n = 100)18–49 years	Vaccine (n = 100)≥ 50 years	Vaccine (n = 50)18–49 years	Vaccine (n = 50)≥ 50 years
Any foreseen local and systemic AEs
Any	77 (77%)*	39 (39%)	9 (18%)*	12 (24%)
Mild (grade 1)	71 (71%)	37 (37%)	9 (18%)	12 (24%)
Moderate (grade 2)	6 (6%)	2 (2%)	0	0
Local reactions
Pain	75 (75%)	39 (39%)	6 (12%)	7 (14%)
Mild (grade 1)	69 (69%)	37 (37%)	6 (12%)	7 (14%)
Moderate (grade 2)	6 (6%)	2 (2%)	0	0
Hyperaemia	14 (14%)	6 (6%)	2 (4%)	8 (16%)
Mild (grade 1)	14 (14%)	6 (6%)	2 (4%)	8 (16%)
Induration	7 (7%)	1 (1%)	0	0
Mild (grade 1)	7 (7%)	1 (1%)	0	0
Itch	1 (1%)	1 (1%)	0	0
Mild (grade 1)	1 (1%)	1 (1%)	0	0
Systemic reactions
Fever	4 (4%)	1 (1%)	1 (2%)	0
Mild (grade 1)	4 (4%)	1 (1%)	1 (2%)	0
General weakness	1 (1%)	1 (1%)	0	1 (2%)
Mild (grade 1)	1 (1%)	1 (1%)	0	1 (2%)
Muscle pain	0	1 (1%)	0	0
Mild (grade 1)	0	1 (1%)	0	0
Drowsiness	1 (1%)	1 (1%)	0	0
Mild (grade 1)	1 (1%)	1 (1%)	0	0
Fatigue	1 (1%)	0	1 (2%)	1 (2%)
Mild (grade 1)	1 (1%)	0	1 (2%)	1 (2%)
Malaise	0	0	1 (2%)	1 (2%)
Mild (grade 1)	0	0	1 (2%)	1 (2%)

Data are presented as n (%). Subjects who developed more than one AE were only counted once. Adverse reactions were graded according to the Guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (US Food and Drug Administration, 2007). *Difference in Any AEs detected after first vs second immunizations is significant in 18–49 years age group. Attributable risk is 0.59 (95%CI 0.42–0.71), calculated by Newcombe/Wilson method with continuity correction.