drugset / Trial / NCT03152903

Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence

NCT03152903

Phase 2/3 Completed 2000 enrolled Serum Institute of India Pvt. Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to calculate efficacy of the vaccine against TB recurrence.

Timeline

Start
2017-12-15
Primary completion
2023-12-29
Completion
2023-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject VPM1002 Vaccine Other

Indications