Clinical trial • Phase I • Infectious Disease
DuoChol Oral Cholera Vaccine for Cholera
Phase I trial of DuoChol Oral Cholera Vaccine for Cholera. Randomised, open-label. 60 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Cholera
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 17-07-2025
- First CTIS Authorization Date
- 06-10-2025
Trial design
Randomised, open-label Phase I trial across 1 site in Sweden.
- Randomised
- Yes
- Open Label
- Yes
- Target Sample Size
- 60
Eligibility
Recruits 60 Vulnerable populations not included; no consent or assent handling details provided..
- Vulnerable Population
- Vulnerable populations not included; no consent or assent handling details provided.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 6
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Sweden
- Earliest CTIS Part Ii Submission Date
- 06-06-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 122
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Studieenheten Akademiskt
- Department Name
- Studieenheten Akademiskt Specialistcentrum
- Principal Investigator Name
- Helena Hervius Askling
- Principal Investigator Email
- helena.hervius.askling@ki.se
- Contact Person Name
- Helena Hervius Askling
- Contact Person Email
- helena.hervius.askling@ki.se
Sponsor
Primary sponsor
- Full Name
- International Vaccine Institute
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Korea, Republic of
Investigational products
- Investigational Product Name
- DuoChol Oral Cholera Vaccine
- Modality
- Vaccine
- Routes Of Administration
- Oral
- Route
- Oral
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