Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants

Summary

This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.

Timeline

Start

2010-07-07

Primary completion

2011-04-30

Completion

2012-03-16

Publications

• Background Idoko OT, Owolabi OA, Owiafe PK, Moris P, Odutola A, Bollaerts A, Ogundare E, Jongert E, Demoitie MA, Ofori-Anyinam O, Ota MO. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine when given as a booster to BCG in Gambian infants: an open-label randomized controlled trial. Tuberculosis (Edinb). 2014 Dec;94(6):564-78. doi: 10.1016/j.tube.2014.07.001. Epub 2014 Aug 9.

Drugs

Indications