Skip to content

Randomized, blinded, single-arm intradermal injection, comparison of similar products on the market, the safety pre-evaluation phase ? clinical trial of BCG-PPD in healthy people

Randomized, blinded, single-arm intradermal injection, comparison of similar products on the market, the safety pre-evaluation phase ?clinical trial of BCG-PPD in healthy people

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038520
Enrollment
Unknown
Registered
2020-09-23
Start date
2020-10-09
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tuberculosis

Interventions

Experimental group:BCG-PPD
Control group:blank

Sponsors

Sichuan Center For Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 0 to 65 years old (including 65 years old), both male and female; (2) agree to participate in this trial and sign an informed consent form; (3) Be able to comply with the requirements of the clinical trial protocol to participate in the follow-up; (4) No history of tuberculosis, family history of tuberculosis, and history of close contact with tuberculosis (referring to direct contact with registered tuberculosis patients 3 months before the diagnosis to 14 days after the start of anti-tuberculosis treatment); (5) No internal and external tuberculosis of the lung, no respiratory symptoms of tuberculosis and symptoms of other parts of the body; (6) After signing the informed consent form, a history of heartlessness, liver, kidney, digestive tract, nervous system, mental disorders, and metabolic disorders after consultation; (7) Vital signs (body temperature (axillary temperature) <37.3 degree C, blood pressure (18 years old and above: systolic blood pressure <140mmHg, diastolic blood pressure <90mmHg; 6-17 years old: systolic blood pressure <120mmHg, diastolic blood pressure <80mmHg; Blood pressure is not measured for people under one year old), pulse 50-100 beats/min, no abnormalities in electrocardiogram, physical examination or abnormalities without clinical significance; (8) Laboratory examinations including blood routine, urine routine, and blood biochemical examination are all abnormal or have no clinical significance.

Exclusion criteria

Exclusion criteria: (1) Suffering from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute ocular meningitis, acute otitis media, generalized skin diseases, and allergies (persons who have a history of allergies to two or more drugs or food , Or known to have allergies and scars to the components of this medicine); (2) Suffer from any serious disease, such as: tumor, progressive atherosclerosis or diabetes with complications, chronic obstructive pulmonary disease that requires oxygen therapy, acute or progressive liver disease or kidney disease, congestive heart failure, etc.; (3) Those who have a history of convulsions, epilepsy, mental illness and/or family history of mental illness; (4) Those who have known or suspected (or high-risk) immune function impairment or abnormalities, such as those receiving immunosuppressive or immunopotentiator therapy, receiving glucocorticoids within 3 months, or those outside the gastrointestinal tract Immunoglobulin preparations or blood products or plasma extracts, human immunodeficiency virus infections or related diseases; (5) The human immunodeficiency virus (HIV) antibody test result is positive; (6) The interval between vaccination of live attenuated vaccine is less than 28 days, and the interval of other vaccines is less than 14 days; (7) Before the skin test, it is in the acute disease stage or chronic disease acute attack stage (3 days before the skin test); (8) Those who are participating in or have participated in any other clinical research within 3 months before this clinical research; (9) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period; (10) On-site inquiries about drug abusers and alcoholics; (11) Those with upper limb disabilities; (12) The birth weight is less than 2.5kg, or premature babies, dystocia babies (applicable to babies under 1 year old); (13) Suffering from neonatal respiratory distress syndrome, pathological jaundice, congenital malformations, developmental disorders and congenital diseases (applicable to babies under 1 year old); (14) The investigator believes that there are any circumstances that may affect the evaluation of the trial, such as poor compliance.

Design outcomes

Primary

MeasureTime frame
Adverse event;

Secondary

MeasureTime frame
scleroma;blush;

Countries

China

Contacts

Public ContactHuang Ting

Sichuan Center For Disease Control and Prevention

cocoht@163.com+86 13330993324

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026