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Shanchol Field Application Study
NCT01762930Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2012
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- icddr,b
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- cholera
01
Overview
Phase 2, open-label trial of cholera vaccine (inactivated, oral) in cholera (6 arms), sponsored by icddr,b. Primary endpoint: Vibriocidal antibody responses at 1 year. Started Jun 2012; status: completed.
02
Design
6 arms- Study design
- Non-randomizedOpen-label
Shanchol 25°C
Vaccine stored at 25°C, 2 doses 14 days apart
Shanchol 37°C
Vaccine stored at 37°C, 2 doses 14 days apart
Shanchol 42°C
Vaccine stored at 42°C, 2 doses 14 days apart
Shanchol 2-8°C (Control)
Vaccine stored at 2-8°C, 2 doses 14 days apart
Shanchol 30-day Interval
Vaccine stored at 2-8°C, 2 doses 30 days apart
Shanchol Single Dose
Vaccine stored at 2-8°C, 1 dose
03
Who it enrols
Healthy adults aged 18-45 without chronic illnesses, recent GI disorders, or recent vaccination/antimicrobial use.
04
Endpoints
Primary
Vibriocidal antibody responses
Secondary
Adverse events
Acute and memory B and T cell responses
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