Trials / Completed
CompletedNCT02543827
Evaluation of the Efficacy and Safety of MV140
Prospective Randomized, Double-blind, Parallel-controlled Versus Placebo in a Polyvalent Sublingual Bacterial Vaccine to 3 Months and 6 Months in Women With RUTI for the Immunomodulatory Efficacy Evaluation, Safety and Clinical Impact
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Inmunotek S.L. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo group.
Detailed description
Double blind parallel placebo controlled study. The subjects will receive medication during three or six months and will be followed up during another twelve months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MV140 | The subjects will receive daily dose of MV140 during 3 or 6 months |
| BIOLOGICAL | Placebo | The subjects will receive daily dose of placebo during 3 or 6 months |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2020-11-04
- Completion
- 2020-12-01
- First posted
- 2015-09-07
- Last updated
- 2021-02-18
Locations
5 sites across 2 countries: Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02543827. Inclusion in this directory is not an endorsement.