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An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Vaccinia-naive Healthy Volunteers
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.
Details
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 88 |
| Start date | 2009-10 |
| Completion | 2011-01 |
Conditions
- Smallpox
Interventions
- smallpox vaccine CJ-50300
Primary outcomes
- Pocket formation — 7-9 day
- Adverse reactions — 0-28 days
Countries
South Korea