GSK REPORTS DATA ON FLU VACCINE IN OVER-65 POPULATION

GlaxoSmithKline (GSK) has released new Phase III data that demonstrate significantly better immune responses in the age range 65 and above when vaccinated with GSK's new-generation (adjuvanted) seasonal flu vaccine compared with a traditional seasonal flu vaccine. These new data are highly important, since the disease burden and death toll is highest among the elderly in each flu season, GSK said.

The data, presented at the Influenza Vaccines for the World 2006 Congress, show the seroprotection rate (90.5 percent) achieved by the new adjuvanted vaccine in the elderly to be more than 25 percent higher than that reported in the age-matched comparator group. Moreover, it greatly exceeds the European licensing requirement for seroprotection, which requires at least 60 percent seroconversion independent of age. Encouraged by these excellent results, GSK has started a new Phase III registration trial in 3,500 patients in Europe and the U.S.

The trial enrolled 275 people and took place in Belgium. In the 65-plus age range, the adjuvanted vaccine elicited higher levels of antibodies (humoral response) compared with non-adjuvanted traditional seasonal flu vaccine in the same population. It was also found to induce a higher cellular immune response to influenza in the elderly compared with the traditional vaccine. The vaccine was well-tolerated throughout the study period and showed a safety profile comparable to the standard seasonal flu vaccine.

The candidate vaccine uses a proprietary novel adjuvant system to enhance the immune response in the older population resulting in similar levels of immune responses typically observed in young adults.