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

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01150942
First received: June 24, 2010
Last updated: January 29, 2014
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Japanese Encephalitis
Biological: JE vaccine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • immunogenicity [ Time Frame: pre-dose, after 3rd vaccination ] [ Designated as safety issue: Yes ]
    the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination


Enrollment: 205
Study Start Date: August 2010
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150942

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
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
Investigators
Principal Investigator: Hoan Jong Lee, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01150942     History of Changes
Other Study ID Numbers: KD287-BR-CT-301
Study First Received: June 24, 2010
Last Updated: January 29, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Boryung Pharmaceutical Co., Ltd:
JEV
vero cell

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 22, 2014