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

NCT00607243 Phase 2/Phase 3 COMPLETED Results posted

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 2/Phase 3
Status	COMPLETED
Enrolment	123
Start date	2008-01
Completion	2008-12

Conditions

• Smallpox

Interventions

• smallpox vaccine CJ-50300

Primary outcomes

• Cutaneous Take Reaction — 7-9 day
  The "take reaction"was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken.
• Adverse Reactions — 0-28 days

Countries

South Korea