WHO ICTRP trial
A study to check the efficacy and safety of recombinant BCG vaccine in…
CTRI/2017/03/008266 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2017/03/008266 |
|---|---|
| Public title | A study to check the efficacy and safety of recombinant BCG vaccine in prevention of TB recurrence. |
| Scientific title | A Multicenter Phase II/III Double – Blind, Randomized, Placebo Controlled study To evaluate the Efficacy and the safety of VPM1002 in the prevention of tuberculosis (TB) recurrence In pulmonary TB patients after successful TB treatment. |
| Primary sponsor | SERUM INSTITUTE OF INDIA PVT LTD |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 2/ Phase 3 |
| Countries | India;Bangladesh |
| Conditions | Health Condition 1: null- Pulmonary TB Patients after successfull TB treatment and were declared cured |
| Interventions | Intervention1: VPM1002: The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis rBCG?ureC::Hly+, freeze-dried and standardized to number of viable mycobacteria (colony forming units; CFU) per application Control… |
| Registration date | Mar 30, 2017 |
| Target size | 2000 |
| Secondary IDs | VPM1002-IN-3.01TBR VERSION:3.0DATED 23 MARCH 2019 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: