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Evaluation of the Efficacy and Safety of MV140

NCT02543827 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-02-18

No results posted yet for this study

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.

Conditions

  • Urinary Tract Infection Bacterial

Interventions

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

Sponsors & Collaborators

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Fernanda Lorenzo, PhD; MD-prof

  • Isidoro Martín, PhD; MD

  • Alfonso Sánchez, PhD; MD

  • Manuel José Vicente, PhD; MD

  • Stephen Foley, FRCS (Urol)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-11-04
Completion
2020-12-31

Countries

  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02543827 on ClinicalTrials.gov