Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-06 @ 9:24 AM
Study NCT ID:
NCT02289794
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2014-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Against Escherichia Coli Infection
Sponsor:
GlycoVaxyn AG
Organization:
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 E.coli-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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013DR1205 | OTHER | swissmedic | View |