70
Participants
Start Date
January 31, 2011
Primary Completion Date
May 31, 2012
Study Completion Date
November 30, 2013
BCG SSI
The dose volume administered for BCG was 0.1 mL, and the mode of administration was ID injection to the deltoid area.
Placebo
This is the identical buffer solution in which H4:IC31 was formulated. The dose volume administered for Placebo was 0.5mL, and the mode of administration was an IM injection.
AERAS-404
AERAS-404 vaccine was reconstituted on site by adding 0.2 mL H4 antigen solution to 0.8 mL IC31 adjuvant solution. The dose volume administered for AERAS-404 was 0.5mL, and the mode of administration was an IM injection.
Centre Hosptialier Universitaire Vaudois (CHUV), Lausanne
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Aeras
OTHER