New data released today demonstrate significantly better immune responses in the age range 65 and above when vaccinated with GSK?s new generation (adjuvanted) seasonal flu vaccine compared to 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. The data, presented at the Influenza Vaccines for the World (IVW) 2006 Congress, showed the seroprotection rate (90.5%) achieved by the new adjuvanted vaccine in the elderly to be more than 25% 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% seroconversion independent of age (CHMP criterion). Encouraged by these excellent results, GSK has started a Phase III registration trial for the vaccine with 3500 patients across three countries in Europe* and in the US.
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.
Lead investigator Dr Isabel Leroux-Roels from the Center for Vaccinology, Ghent University and Hospital said: ?The immune response of the elderly can be significantly lower than in younger adults leaving them particularly vulnerable to the more serious complications of flu. There is a real need to strengthen the immune response of the population of 65 years and above. This can be achieved by combining antigen components of annual flu vaccine with GSK?s novel adjuvant system.?
Dr Philippe Monteyne, Head of Global Vaccine Development, GSK Biologicals said:
?These data highlight how GSK?s new adjuvant system can be effectively used to enhance vaccine-induced immune responses. Our new vaccine increased the immune response in the elderly to levels comparable to that observed for traditional seasonal flu vaccine in younger adults. This promising new vaccine will build on our strong existing flu franchise.?
High immune response with adjuvanted vaccines
Two hundred and seventy five people were involved in the trial which ran from Q3 2005 to Q2 2006 in Belgium. In the 65+ age range the adjuvanted vaccine elicited higher levels of antibodies (humoral response) compared to 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 to the traditional vaccine. The vaccine was well tolerated throughout the study period and showed a safety profile which is comparable to the standard seasonal flu vaccine.
Phase III studies
In the wake of the encouraging results from this trial, a new multinational Phase III programme involving 3500 participants has recently commenced that sets out to confirm the findings from today?s data. This pivotal Phase III immunogenicity trial will take place in three countries in Europe* as well as in the US. The results, expected in 2007 will form a significant part of the data package for file submission.
GSK, a leader in flu treatment and preparedness
GSK has an active research and development programme targeted at both seasonal and pandemic influenza and has recently committed over $2 billion to expand capacity for manufacturing flu vaccine and its anti-viral influenza treatment Relenza? (zanamivir for inhalation). In North America, GSK acquired a major influenza vaccine manufacturer, ID Biomedical Corporation in 2005.
GSK is one of the world?s leading research-based pharmaceutical and health care companies. GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com.
* The Phase III trial will be carried out in Belgium, Germany, Norway and the US.
Notes to editors
Seasonal Influenza or ‘flu’ is a respiratory illness associated with infection by influenza virus. There are two main types that cause infection: influenza A and influenza B. The influenza virus is unstable and new strains and variants are constantly emerging.
Fluarix?, manufactured by GSK Biologicals, is a standard trivalent influenza vaccine recommended for prophylaxis against influenza in different age groups includingpeople aged over 65 years and people who run an increased risk of complications if they get flu.
FluLaval? is a second standard trivalent influenza vaccine manufactured by GSK Biologicals that was recently licensed by the FDA in the US.
Fluarix, FluLaval (sold under the tradename Fluviral in Canada) and Relenza are registered trade marks of the GlaxoSmithKline group of companies.