Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290089
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-26
Brief Title:
Pre-Study of Wild Type Enterotoxigenic E Coli ETEC Strain for Verification of a Planned Challenge Dose
Sponsor:
Scandinavian Biopharma AB
Organization:
Scandinavian Biopharma AB
Study Overview
Official Title:
Pre-Study of Wild Type Enterotoxigenic E Coli ETEC Strain for Verification of a Planned Challenge Dose
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label study with the aim to estimate the incidence of moderate and severe diarrhea among participants challenged with an enterotoxigenic E coli ETEC strain This strain is planned to be used in a subsequent challenge study on the efficacy of an oral inactivated ETEC vaccine
The study will be conducted at one site the Center for Immunization Research Johns Hopkins Bloomberg School of Public Health in Baltimore Maryland United States
The study will be conducted at one site the Center for Immunization Research Johns Hopkins Bloomberg School of Public Health in Baltimore Maryland United States
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None