Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults

Summary

This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.

Timeline

Start

2011-08-12

Primary completion

2011-11-29

Completion

2012-09-28

Publications

• Godeaux O, Izurieta P, Madariaga M, Drame M, Li P, Vaughn DW. Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years. Vaccine. 2015 Apr 27;33(18):2189-95. doi: 10.1016/j.vaccine.2014.07.062. Epub 2014 Jul 30.

Drugs

Indications