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Efficacy and Safety of Anthrax Vaccine, GC1109

Anthrax Clinical Trial

Official title:
A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men

Clinical Trial Summary

1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.

2. OBJECTIVE

- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.

3. STUDY DESIGN

- single-blinded

- randomized

- placebo controlled

- phase 1 study

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01867957
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 1
Start date February 2009
Completion date December 2009
View Details
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