1,044
Participants
Start Date
March 31, 2015
Primary Completion Date
July 31, 2015
Study Completion Date
September 30, 2015
5μg/ml ESAT6-CFP10
The participants are injection intradermally with 0.1 ml 5μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 5μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II .
10μg/ml ESAT6-CFP10
The participants are injection intradermally with 0.1 ml 10μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 10μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II .
BCG
The participants are injected intradermally with 0.1 ml BCG.This BCG is Freeze-dried agent and with five people dose of each bottle,so each bottle of BCG must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II .
placebo
The participants are injected intradermally with 0.1 ml placebo of Bacillus Calmette-Guerin.This placebo is Freeze-dried agent and with five people dose of each bottle ,so each bottle must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II .
Jurong Province Centers for Disease Control and Prevention, Jurong
Air Force Military Medical University, China
OTHER
Proswell Medical Corporation
INDUSTRY
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Jurong Province Centers for Disease Control and Prevention
OTHER
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
INDUSTRY