Tuberculosis Clinical Trial
Official title:
A Randomized Clinical Trial in Adults and Newborns to Compare the Safety, Reactogenicity and Immunogenicity of BCG Administration Via a Disposable Syringe Jet Injector (DSJI) to BCG Administration Via Syringe and Needle
The study is designed to test the hypothesis that BCG administration via jet injector will
produce a comparable immune response and that there will be no significant differences in
safety or reactogenicity between BCG administration via jet injector and needle and syringe.
The primary objectives of this study are to...
1. Compare the safety and reactogenicity of BCG administered intradermally by a jet
injector device in adults and infants, to BCG administered intradermally by needle and
syringe;
2. Compare the specific T cell immunity in neonates vaccinated with BCG via the jet
injector device to infants vaccinated with BCG via needle and syringe.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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