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

Boryung

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis

Treatments: Biological: JE vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01150942

KD287-BR-CT-301

Details and patient eligibility

About

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

Full 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

Enrollment: 205 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children aged 12-23 months
• Written informed consent

Exclusion criteria

• History of documented HIV
• Known or suspected impairment of immunologic function
• History of serious chronic disease
• Received any JE vaccine prior to enrollment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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205 participants in 2 patient groups

vero cell-derived JE vaccine

Experimental group

Description:

vero cell-derived vaccine group

Treatment:

Biological: JE vaccine

Mouse brain-derived JE vaccine

Active Comparator group

Description:

Mouse brain-derived JE vaccine group

Treatment:

Biological: JE vaccine