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

January 29, 2014 updated by: Boryung Pharmaceutical Co., Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vero cell-derived JE vaccine
vero cell-derived vaccine group
Biological: JE vaccine
3 times, IM
ACTIVE_COMPARATOR: Mouse brain-derived JE vaccine
Mouse brain-derived JE vaccine group
Biological: JE vaccine
3 times, IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunogenicity
Time Frame: pre-dose, after 3rd vaccination
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
pre-dose, after 3rd vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Collaborators

Samsung Medical Center
Seoul National University Hospital
Gachon University Gil Medical Center
Inje University
Ewha Womans University
The Catholic University of Korea
Wonju Severance Christian Hospital
Kyunghee University Medical Center
Inha University Hospital
Korea Cancer Center Hospital

Investigators

  • Principal Investigator: Hoan Jong Lee, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (ESTIMATE)

June 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD287-BR-CT-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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