NCT00607243

Safety and Efficacy of CJ-50300 in Healthy Volunteers

Randomized, Double Blind, a Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CJ-50300 in Healthy Volunteers

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	smallpox vaccine CJ-50300	Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-06-01
• Completion: 2008-12-01
• First posted: 2008-02-05
• Last updated: 2013-07-09
• Results posted: 2013-07-09

Locations

1 site across 1 country: South Korea