NCT00336635

Safety and Immunogenicity of CJ-50300

Randomized, Double Blind, Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers : Phase I

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 28 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 is 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 phase 1 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	cell-culture derived smallpox vaccine

Timeline

• Start date: 2006-06-01
• Completion: 2007-02-01
• First posted: 2006-06-14
• Last updated: 2007-04-19

Locations

1 site across 1 country: South Korea