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Table 2 Incidence of solicited adverse events within 7 days after each vaccination (safety population)

From: Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC®) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial

  Severity 1 st dose, n*(%) 2 nd dose, n*(%) 3 rd dose, n*(%)
KD-287 (n = 102) JEV-GCC (n = 102) KD-287 (n = 102) JEV-GCC (n = 100) KD-287 (n = 100) JEV-GCC (n = 96)
Erythema Mild 9 (8.8) 18 (17.6) 7 (6.9) 14 (14.0) 7 (7.0) 14 (14.6)
Moderate 3 (2.9) 2 (2.0) 5 (4.9) 2 (2.0) 7 (7.0) 6 (6.3)
Severe 1 (1.0) 0 (0) 0 (0) 0 (0) 1 (1.0) 0 (0)
Pain Mild 14 (13.7) 10 (9.8) 3 (2.9) 5 (5.0) 18 (18.0) 11 (11.5)
Moderate 2 (2.0) 2 (2.0) 2 (2.0) 1 (1.0) 2 (2.0) 3 (3.1)
Severe 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (1.0)
Swelling Mild 3 (2.9) 7 (6.9) 6 (5.9) 7 (7.0) 5 (5.0) 11 (11.5)
Moderate 2 (2.0) 1 (1.0) 2 (2.0) 1 (1.0) 1 (1.0) 2 (2.1)
Severe 1 (1.0) 0 (0) 0 (0) 0 (0) 1 (1.0) 0 (0)
Fever Mild 19 (18.6) 10 (9.8) 13 (12.7) 12 (12.0) 13 (13.0) 14 (14.6)
Moderate 8 (7.8) 4 (3.9) 2 (2.0) 4 (4.0) 1 (1.0) 3 (3.1)
Severe 4 (3.9) 1 (1.0) 2 (2.0) 3 (3.0) 0 (0) 1 (1.0)
Crying Mild 27 (26.5) 20 (19.6) 15 (14.7) 6 (6.0) 14 (14.0) 14 (14.6)
Moderate 5 (4.9) 4 (3.9) 3 (2.9) 6 (6.0) 2 (2.0) 3 (3.1)
Severe 2 (2.0) 0 (0) 0 (0) 1 (1.0) 0 (0) 1 (1.0)
Irritability Mild 12 (11.8) 11 (10.8) 5 (4.9) 6 (6.0) 13 (13.0) 4 (4.2)
Moderate 1 (1.0) 4 (3.9) 2 (2.0) 5 (5.0) 0 (0) 6 (6.3)
Severe 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Vomiting Mild 8 (7.8) 11 (10.8) 4 (3.9) 3 (3.0) 1 (1.0) 4 (4.2)
Moderate 2 (2.0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Severe 1 (1.0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Diarrhea Mild 17 (16.7) 11 (10.8) 3 (2.9) 5 (5.0) 3 (3.0) 4 (4.2)
Moderate 4 (3.9) 1 (1.0) 0 (0) 2 (2.0) 0 (0) 2 (2.1)
Severe 0 (0) 1 (1.0) 0 (0) 0 (0) 1 (1.0) 1 (1.0)
Decreased appetite Mild 10 (9.8) 13 (12.7) 5 (4.9) 8 (8.0) 6 (6.0) 8 (8.3)
Moderate 2 (2.0) 0 (0) 0 (0) 1 (1.0) 1 (1.0) 0 (0)
Severe 2 (2.0) 0 (0) 1 (1.0) 0 (0) 0 (0) 1 (1.0)
Somnolence Mild 9 (8.8) 12 (11.8) 8 (7.8) 7 (7.0) 14 (14.0) 17 (17.7)
Moderate 0 (0) 1 (1.0) 0 (0) 1 (1.0) 0 (0) 0 (0)
Severe 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
  1. *Number of subjects reporting the specific characteristic.