NCT05746611CompletedPhase 4
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 7500 (actual)
- First submitted
- 9 Feb 2023
- Start date
- 17 Apr 2023
- Primary completion date
- 13 May 2024
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Diseases
- Tuberculosis
- NCT number
- NCT05746611
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 7500
- From 17 Apr 2023 to the primary completion date, 13 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A pure protein derivative or similar product was used within 3 months prior to the initiation of this trial.
- Participated in other new drug clinical trials within 3 months prior to clinical trials.
Other illness
- Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic diseases
Other
- Any circumstances were considered by the investigators to have the potential to influence the assessment of the trial.
Who the study is looking for
- People aged 6 months and above (≥6 months).
- Normal armpit body temperature (body temperature below 37.5℃ from 6 months to 14 years old, body temperature below 37.3℃ from 15 years old and above).
- I or my guardian agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of this clinical study protocol.
Age in the registry: 6 months to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.