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

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JE vaccine
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Japanese Encephalitis focused on measuring JEV, vero cell

Eligibility Criteria

12 Months - 23 Months (Child)All SexesAccepts 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vero cell-derived JE vaccine

Mouse brain-derived JE vaccine

Arm Description

vero cell-derived vaccine group

Mouse brain-derived JE vaccine group

Outcomes

Primary Outcome Measures

immunogenicity
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination

Secondary Outcome Measures

Full Information

First Posted
June 24, 2010
Last Updated
January 29, 2014
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
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1. Study Identification

Unique Protocol Identification Number
NCT01150942
Brief Title
Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
Keywords
JEV, vero cell

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vero cell-derived JE vaccine
Arm Type
Experimental
Arm Description
vero cell-derived vaccine group
Arm Title
Mouse brain-derived JE vaccine
Arm Type
Active Comparator
Arm Description
Mouse brain-derived JE vaccine group
Intervention Type
Biological
Intervention Name(s)
JE vaccine
Intervention Description
3 times, IM
Primary Outcome Measure Information:
Title
immunogenicity
Description
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
Time Frame
pre-dose, after 3rd vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoan Jong Lee, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25567119
Citation
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.
Results Reference
derived

Learn more about this trial

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

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