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P1113 / AERAS-404 TB Vaccine in BCG-Primed Infants
Phase I/II, Safety and Immunogenicity Study of a Recombinant Protein Tuberculosis Vaccine (AERAS-404) in BCG-Primed Infants
Study Status
Concluded
DAIDS Number
11911
IND Number
Non-IND
Primary Protocol Team Members
Summary
P1113 is a Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and dose-range finding study of the AERAS-404 tuberculosis vaccine in HIV-unexposed, HIV-uninfected, BCG-primed South African infants. The study is being conducted in collaboration with AERAS, Sanofi Pasteur, and Statens Serum Institut.
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