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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01150942
Enrollment
205
Registered
2010-06-25
Start date
2010-08-31
Completion date
2013-02-28
Last updated
2014-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese Encephalitis

Keywords

JEV, vero cell

Brief 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

Interventions

BIOLOGICALJE vaccine

3 times, IM

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
immunogenicitypre-dose, after 3rd vaccinationthe seroconversion rates for JE antibodies 4 weeks after 3rd vaccination

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026