Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children

PHASE3CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

October 31, 2017

Study Completion Date

March 31, 2018

Conditions
Tuberculosis Diagnosis
Interventions
BIOLOGICAL

ESAT6-CFP10 in left arm and TB-PPD in right arm

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.

BIOLOGICAL

ESAT6-CFP10 in right arm and TB-PPD in left arm

All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.

Trial Locations (4)

Unknown

Wuhan Medical Treatment Center, Wuhan

Beijing Children's Hospital, Beijing

Shanghai Public Health Clinical Center, Shanghai

Wuhan Institute for Tuberculosis Control, Wuhan

All Listed Sponsors
collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

collaborator

Beijing Children's Hospital

OTHER

collaborator

Wuhan Institute for Tuberculosis Control

OTHER

collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

lead

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

NCT03027154 - Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen for Children | Biotech Hunter | Biotech Hunter