Table 2.

Local and systemic reactions occurring in the Zagreb and Essen groups after the first vaccination and during the whole trial duration

	After First Vaccination		During the Whole Trial
	Zagreb group (n = 549)	Essen group (n = 275)	Zagreb group (n = 549)	Essen group (n = 275)	P value
Local AEs, any, n (%)			483 (87.9)	241 (87.6)	0.88
Local AEs, n (%)
Erythema	31 (5.7)	10 (3.6)
Mild	0 (0.0)	1 (0.4)	37 (6.7)	17 (6.2)
Moderate			0 (0.0)	1 (0.4)
Swelling
Mild	18 (3.3)	11 (4.0)	42 (7.7)	38 (13.8)
Pain
Mild	392 (71.4)	180 (65.5)	443 (80.7)	215 (78.2)
Moderate	17 (3.1)	4 (1.5)	32 (5.8)	20 (7.3)
Severe	0 (0.0)	0 (0.0)	0 (0.0)	1 (0.4)
Systemic AEs, any, n (%)			177 (32.2)	103 (37.4)	0.13
Systemic AEs, n (%)
Fever
Mild	75 (13.7)	46 (16.7)	106 (19.3)	58 (21.1)
Moderate	11 (2.0)	5 (1.8)	17 (3.1)	10 (3.6)
Severe	1 (0.2)	0 (0.0)	1 (0.2)	0 (0.0)
Shivering
Mild	9 (1.6)	3 (1.1)	18 (3.3)	8 (2.9)
Moderate	1 (0.2)	0 (0.0)	1 (0.2)	0 (0.0)
Severe	0 (0.0)	0 (0.0)	2 (0.4)	0 (0.0)
Malaise
Mild	23 (4.2)	1 (0.4)	34 (6.2)	16 (5.8)
Moderate	1 (0.2)	0 (0.0)	1 (0.2)	1 (0.4)
Headache
Mild	44 (8.0)	16 (5.8)	84 (15.3)	44 (16.0)
Moderate	4 (0.7)	3 (1.1)	7 (1.3)	5 (1.8)
Nausea
Mild	14 (2.5)	8 (2.9)	26 (4.7)	24 (8.7)
Moderate	0 (0.0)	0 (0.0)	2 (0.4)	0 (0.0)
Myalgia
Mild	9 (1.6)	0 (0.0)	24 (4.4)	20 (7.3)
Moderate	2 (0.4)	0 (0.0)	4 (0.7)	3 (1.1)
Severe	0 (0.0)	0 (0.0)	1 (0.2)	0 (0.0)
Arthralgia
Mild	5 (0.9)	1 (0.4)	11 (2.0)	12 (4.4)
Moderate	2 (0.4)	0 (0.0)	2 (0.4)	1 (0.4)
Fatigue
Mild	26 (4.7)	12 (4.4)	57 (10.4)	34 (12.4)
Moderate	2 (0.4)	0 (0.0)	4 (0.7)	0 (0.0)
Rash
Mild	0 (0.0)	0 (0.0)	3 (0.5)	3 (1.1)