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Clinical Trial of Mica
Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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
Conditions
Interventions
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