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Phase III Clinical Study of Efficacy and Safety of Mycobacterium Vaccae to Prevent Tuberculosis in High Risk Groups of Tuberculosis Infection
Mycobacterium Vaccae for Injection (Trade Name "Vaccae") is a kind of bio-products developed by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,and got "The New Drug Certificate "in 1999. Vaccae has been approved for adjuvant therapy of tuberculosis(TB), and is also the only recommended drug in TB immunotherapy by WHO. It was approved for production and sale by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd. in 2001, and got favourable comment in therapy of tuberculosis. The purpose of this study is to add new indications for Vaccae, mainly to prevent Tuberculosis for high risk groups of Tuberculosis Infection . In December 2012, China Food and Drug Administration approved of the plan "Phase III Clinical Study of Efficacy and Safety of Mycobacterium Vaccae to Prevent Tuberculosis in high risk groups of Tuberculosis Infection". In the test, 10,000 cases whose skin tests of PPD are strongly positive are enrolled. Using random, double-blind, and placebo-controlled methods, the study is carried out to evaluate the efficacy and safety of Vaccae in preventing Tuberculosis. Meanwhile, in this test, TB incidence and degree of pathological changes of experimental group are lower than that of control group, and no drug-related SAEs are reported in treatment groups.
Details
| Lead sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 10000 |
| Start date | 2013-10 |
| Completion | 2017-11-26 |
Conditions
- Tuberculosis
Interventions
- Vaccae
- placebo
Primary outcomes
- The whole TB incidence after injection of Vaccae — Terminal Stage: two years after the last group of subjects enrolled
Medium-term: one year after the last group of subjects enrolled or after observation of 38 cases of the disease, Terminal Stage: two years after the last group of subjects enrolled or after observation of 76 cases of the disease
Countries
China