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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

Closed to Follow Up

DAIDS Number

11911

IND Number

Non-IND

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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