Skip to main content

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.