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Table 3 Incidence of serious adverse events requiring hospitalization (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

Adverse events No. of subjects, n (%) p -value*
KD-287 (n = 102) JEV-GCC (n = 102)
Total 17 (16.67) 23 (22.55) 0.373
Febrile seizure 1 (0.98) - 1.000
Otitis Media 1 (0.98) 1 (0.98) 1.000
Pharyngitis 2 (1.96) 1 (0.98) 1.000
Laryngitis 1 (0.98) - 1.000
Bronchitis 4 (3.92) 4 (3.92) 1.000
Pneumonia 5 (4.90) 13 (12.75) 0.127
Influenza - 1 (0.98) 1.000
Gastroenteritis 1 (0.98) 3 (2.94) 0.369
Others 2 (1.96) - 0.498
  1. *The p-value was calculated using the chi-square or Fisher’s exact test.
  2. Others included a case of vaccine overdose and a case of accessory skin tag.