Status:
SUSPENDED
BCG Revaccination in Children and Adolescents
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborating Sponsors:
Institute of Child Health, Chennai
All India Institute of Medical Sciences
Conditions:
Tuberculosis Infection
Tuberculosis
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
Bacille Calmette Guerin (BCG) vaccine is one of the most used vaccines of the world, to reduce the risks of natural tuberculous infection. The efficacy of BCG vaccination in newborns is well known and...
Detailed Description
Objectives Primary: To demonstrate the effect of BCG revaccination in comparison to oral chemoprophylaxis on the incidence of Mycobacterium tuberculosis disease in healthy household contacts aged 6-...
Eligibility Criteria
Inclusion
- Healthy household contacts aged 6 to 18 yr
- Previously vaccinated with BCG at birth or least 5 years ago - evidence of scar or documented immunisation record.
- General good health - through history and baseline screening
- Agrees to continue in the study for 2 years post enrollment
- Children previously treated for LTBI and completed treatment at least 6 months ago - can also be included. However, they should be current HHC
Exclusion
- Any acute illness on recruitment day (Evaluate the child again at a later stage)
- Fever ≥38 degree Celsius on recruitment day (Evaluate the child again at a later)
- History of autoimmune disease
- Pregnancy - female participants \> 15 years of age will have pregnancy test done after caretakers and participants informed consent
- Evidence of active TB disease
- On treatment for active TB disease or LTBI
- HIV positive or any history or present possible immunodeficiency condition
- History of allergic reactions to vaccines in past
- Pre-existing liver dysfunction
- ALT/AST is ≥ 3 times upper limit of normal (ULN) in the presence of symptoms or ≥ 5 times the ULN in the absence of symptoms and/or total bilirubin greater than ULN along with raised ALT/AST.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
9200 Patients enrolled
Trial Details
Trial ID
NCT05330884
Start Date
July 15 2024
End Date
December 1 2027
Last Update
December 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr Aishwarya Venkataraman
Chennai, Tamil Nadu, India, 600031