A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.

Summary

This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic influenza vaccine.

Timeline

Start

2008-11-15

Primary completion

2009-06-07

Completion

2009-06-07

Outcome

Met primary endpoint

paper Twenty-one days after the second dose of vaccine, both groups met the CHMP criteria for vaccine-homologous HI response PMID 22748624 ↗

Publications

• Yang PC, Yu CJ, Chang SC, Hsieh SM, Drame M, Walravens K, Roman F, Gillard P. Safety and immunogenicity of a split-virion AS03A-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine in Taiwanese adults. J Formos Med Assoc. 2012 Jun;111(6):333-9. doi: 10.1016/j.jfma.2011.02.006. Epub 2012 Apr 20.

Drugs

Indications