At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 240 enrolled
Drug / intervention
MV140 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating MV140 and Placebo for Urinary Tract Infection Bacterial. Completed, enrolled 240 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infection Bacterial
CountriesSpain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartNov 2015
Primary CompletionNov 2020
Study CompletionDec 2020
TodayJul 2026
First PostedSep 7, 2015
Enrollment StartNov 1, 2015
Primary CompletionNov 4, 2020
Study CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 10.8 years ago
Interventions
MV140biological
The subjects will receive daily dose of MV140 during 3 or 6 months
Placebobiological
The subjects will receive daily dose of placebo during 3 or 6 months