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

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ClinicalTrials.gov Identifier: NCT01150942
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : January 30, 2014
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

June 24, 2010
June 25, 2010
January 30, 2014
August 2010
September 2012   (Final data collection date for primary outcome measure)
immunogenicity [ Time Frame: pre-dose, after 3rd vaccination ]
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
Same as current
Complete list of historical versions of study NCT01150942 on ClinicalTrials.gov Archive Site
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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
To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12~23 months
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Japanese Encephalitis
Biological: JE vaccine
3 times, IM
  • Experimental: vero cell-derived JE vaccine
    vero cell-derived vaccine group
    Intervention: Biological: JE vaccine
  • Active Comparator: Mouse brain-derived JE vaccine
    Mouse brain-derived JE vaccine group
    Intervention: Biological: JE vaccine
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®) 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
188
February 2013
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Months to 23 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01150942
KD287-BR-CT-301
Yes
Not Provided
Not Provided
Boryung Pharmaceutical Co., Ltd
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
Principal Investigator: Hoan Jong Lee, PhD Seoul National University Hospital
Boryung Pharmaceutical Co., Ltd
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP