Trials / Completed
CompletedNCT01867957
Efficacy and Safety of Anthrax Vaccine, GC1109
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Low-dose GC1109 | 50ug/dose |
| BIOLOGICAL | High-dose GC1109 | 100ug/dose |
| BIOLOGICAL | Low-dose Placebo | 0.9% Saline 0.5 mL |
| BIOLOGICAL | High-dose Placebo | 0.9% Saline 1.0 mL |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2013-06-04
- Last updated
- 2013-06-05
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01867957. Inclusion in this directory is not an endorsement.