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Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

NCT05746611 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7500

Last updated 2024-09-19

No results posted yet for this study

Summary

Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only

Conditions

  • Latent Tuberculosis Infection

Interventions

BIOLOGICAL

Recombinant Mycobacterium tuberculosis fusion protein for injection

For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method

BIOLOGICAL

TB-PPD was injected

For the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method

Sponsors & Collaborators

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yi Mo, Master · Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2024-05-13
Completion
2024-05-13

Countries

  • China

Study Locations

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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 NCT05746611 on ClinicalTrials.gov