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CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers
NCT01317238Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2010
- Primary completion
- Jul 2011
- Countries
- 1
- Sponsor
- Seoul National University Hospital
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- smallpox
01
Overview
Phase 3, open-label, single-arm trial of Smallpox Vaccine MRC-5 in smallpox, sponsored by Seoul National University Hospital. Primary endpoints: Pocket formation (Cutaneous take reaction) and Adverse reactions. Started Oct 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
CJ Vaccination arm
Healthy vaccinia-experienced volunteers receiving CJ smallpox vaccine
03
Who it enrols
Healthy adults aged ~31-60 (born before 1979) who have been previously vaccinated with smallpox vaccine. Excludes those with immunodeficiency, eczema/atopic dermatitis, cardiac disease history, or recent steroid/immunosuppressant use.
04
Endpoints
Primary
Pocket formation (Cutaneous take reaction)
Adverse reactions
Secondary
Antibody response
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