Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02289794
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2014-11-03
Brief Title:
Vaccine Against Escherichia Coli Infection
Sponsor:
GlycoVaxyn AG
Organization:
GlycoVaxyn AG
Study Overview
Official Title:
Evaluation of a Candidate Vaccine Against Uropathogenic Escherichia Coli in Women With a Clinical History of Recurrent Urinary Tract Infection
Status:
COMPLETED
Status Verified Date:
2016-02
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 Phase I multi-center placebo controlled study is conducted in healthy women with a history of recurrent urinary tract infections UTI aged between 18 and 70 years
Detailed Description:
GlycoVaxyn is a Swiss company that has developed a multivalent bioconjugate vaccine for the prevention of Ecoli-infections Cystitis is the most common UTI however kidney infections or bacteremia are possible The E coli bacterium is responsible for 85 of all UTIs
The objectives of this trial are to assess the safety and ability to elicit an immune response of the candidate vaccine as well as the effectiveness of the vaccine in the reduction in UTIs
The objectives of this trial are to assess the safety and ability to elicit an immune response of the candidate vaccine as well as the effectiveness of the vaccine in the reduction in UTIs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013DR1205 | OTHER | swissmedic | None |