Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above

PHASE3RecruitingINTERVENTIONAL
Enrollment

780

Participants

Timeline

Start Date

August 3, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

October 31, 2025

Conditions
Latent Tuberculosis Infection
Interventions
BIOLOGICAL

Recombinant Mycobacterium Tuberculosis Fusion Protein

"Dosage form:injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle.~1\. This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm."

BIOLOGICAL

Purified Protein Derivative of Tuberculin

"Dosage form:injection. Main ingredients and contents:Pure protein derivatives of tuberculin,0.1ml per bottle.~Usage:0.1ml (5IU) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method."

Trial Locations (8)

Unknown

RECRUITING

The First Affiliated Hospital of Bengbu Medical University, Bengbu

NOT_YET_RECRUITING

Anhui Chest Hospital, Hefei

RECRUITING

Guangzhou Municipal Hospital of Chest Medicine, Guangzhou

RECRUITING

The Third People's Hospital Of Shenzhen, Shenzhen

RECRUITING

LiuZhou People's Hospital, Liuzhou

RECRUITING

Changsha Central Hospital, Changsha

RECRUITING

Wuxi NO.5 People's Hospital, Wuxi

RECRUITING

Wuhan Institute for Tuberculosis Control, Wuhan

All Listed Sponsors
lead

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY