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

• Sponsor: Boryung Pharmaceutical Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01150942
• Collaborator: Seoul National University Hospital (Other), Gachon University Gil Medical Center (Other), Inha University Hospital (Other), Inje University (Other), Korea Cancer Center Hospital (Other), Samsung Medical Center (Other), The Catholic University of Korea (Other), Ewha Womans University (Other), Wonju Severance Christian Hospital (Other), Kyunghee University Medical Center (Other)
• Enrollment: 205
• Location: 1
• Arms: 2
• Duration (Months): 30.1
• Patients Per Site Per Month: 6.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Japanese Encephalitis	Biological: JE vaccine	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. immunogenicity [pre-dose, after 3rd vaccination]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 23 Months
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boryung Pharmaceutical Co., Ltd
• ClinicalTrials.gov Identifier: NCT01150942
• Other Study ID Numbers: KD287-BR-CT-301
• First Posted: Jun 25, 2010
• Last Update Posted: Jan 30, 2014
• Last Verified: Feb 1, 2011

• Keywords provided by Boryung Pharmaceutical Co., Ltd: JEV; vero cell
• Additional relevant MeSH terms: Encephalitis, Japanese; Encephalitis

Study Results

No Results Posted as of Jan 30, 2014