CompletedNCT01150942Updated Jan 30, 2014

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

A Phase 3 interventional study of JE vaccine in Japanese Encephalitis, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 12 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-30.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 205
Allocation: Randomized
Ages: 12 Months to 23 Months
Sex: All

Study summary

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

Read the 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 studied

Japanese Encephalitis

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Keywords

JEV
vero cell

In context

Encephalitis, Japanese

77 studies on the registry are indexed under Encephalitis, Japanese; 4 are open to participants now.

This study's enrollment of 205 is below the median of 278 across 69 interventional studies indexed under Encephalitis, Japanese.

Browse Encephalitis, Japanese studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Months to 23 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy children aged 12-23 months
Written informed consent

Exclusion criteria

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

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 205 participants (actual)

Study arms

Experimental
vero cell-derived JE vaccine
vero cell-derived vaccine group
Biological: JE vaccine
Active comparator
Mouse brain-derived JE vaccine
Mouse brain-derived JE vaccine group
Biological: JE vaccine

Interventions

BiologicalJE vaccine
3 times, IM

What researchers measure

Primary outcomes

immunogenicity
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
Time frame: pre-dose, after 3rd vaccination

Study locations

1 site

Seoul National University Hospital
Seoul, Korea, Republic of

References and documents

Publications

Yun KW, Lee HJ, Kang JH, Eun BW, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC(R)) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial. BMC Infect Dis. 2015 Jan 8;15:7. doi: 10.1186/s12879-014-0744-4. PubMed 25567119 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01150942
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Collaborators: Seoul National University Hospital, Gachon University Gil Medical Center, Inha University Hospital, Inje University, Korea Cancer Center Hospital, Samsung Medical Center, The Catholic University of Korea, Ewha Womans University, Wonju Severance Christian Hospital, Kyunghee University Medical Center
Responsible party: Sponsor
First posted: Jun 25, 2010
Start date: Aug 2010
Primary completion: Sep 2012
Completion: Feb 2013
Last update: Jan 30, 2014

Study contacts

Hoan Jong Lee, PhD

principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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