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ACTIVE NOT RECRUITING
NCT05680415
PHASE4

Clinical Trial of Mica

Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: Phase IV Clinical Trial of the Safety, Efficacy, and Immunogenicity of Mycobacterium Vaccae for Injection (Mica) in People Over 15 Years of Age With Latent Mycobacterium Tuberculosis Infection

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6800

Start Date

2023-04-19

Completion Date

2027-08-31

Last Updated

2024-06-25

Healthy Volunteers

Yes

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.

Locations (2)

Liujiang district Prevention and Control center

Liuchow, Guangxi, China

Liuzhou Center for Disease Control and Prevention

Liuchow, Guangxi, China