NCT01150942

Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea

A Multi-center, Active-control, Randomized, Double-blind Phase 3 Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine 'KD-287(JEIMMUGEN INJ.) in Korean Healthy Children Aged 12~23 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12\~23 months

Detailed description

To compare the Vero cell-derived inactivated Japanese encephalitis(JE) vaccine 'KD-287(JEIMMUGEN INJ.)' with the mouse brain-derived inactivated JE vaccine in terms of the immunogenicity and safety, in Korean healthy children aged 12\~23 months

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	JE vaccine	3 times, IM

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-09-01
• Completion: 2013-02-01
• First posted: 2010-06-25
• Last updated: 2014-01-30

Locations

1 site across 1 country: South Korea