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Clinical Trial of Mica

NCT05680415 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6800

Last updated 2024-06-25

No results posted yet for this study

Summary

This study used a randomized, open, blank control design. A total of 6800 patients over 15 years old with latent mycobacterium tuberculosis infection who met the inclusion criteria but did not meet the exclusion criteria were randomly assigned to the experimental group and the blank control group in a 1:1 ratio, with 3400 patients in each group. The experimental group was alternately injected with 1 dose of microcard every two weeks (0-2-4-6-8-10 weeks) in the left and right hip muscle deep, with a total of 6 doses. The blank control group was not injected with drugs.

Conditions

  • Latent Tuberculosis Infection

Interventions

BIOLOGICAL

Mycobacterium Vaccae for Injection

The experimental group was alternately injected with 1 dose of microcard every two weeks (0-2-4-6-8-10 weeks) in the left and right hip muscle deep, and a total of 6 doses were injected.

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
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2026-09-30
Completion
2027-08-31

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 NCT05680415 on ClinicalTrials.gov