P1113 (DAIDS ID 11911): Phase I/II, Safety and Immunogenicity Study of a Recombinant Protein Tuberculosis Vaccine (AERAS-404) in BCG-Primed Infants

Study Status Study Restriction

Closed to Follow Up


What is P1113?

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.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country
No records returned.

Study contacts:

Clinical Trials Specialist: Anne Coletti

CTS: Anne Coletti and Lisa Levy


Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.