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

Japanese Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150942
• Other study ID #: KD287-BR-CT-301
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2010
• Last updated: January 29, 2014
• Start date: August 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2011
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 23 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• JE vaccine
3 times, IM

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (11)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd	Ewha Womans University, Gachon University Gil Medical Center, Inha University Hospital, Inje University, Korea Cancer Center Hospital, Kyunghee University Medical Center, Samsung Medical Center, Seoul National University Hospital, The Catholic University of Korea, Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunogenicity	the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination	pre-dose, after 3rd vaccination	Yes