GlaxoSmithKline says trial shows Pandemrix has strong response

LONDON -- GlaxoSmithKline announced Nov. 23 that more than 40 million doses of its adjuvanted pandemic H1N1 vaccine have been distributed to countries globally for use in government-initiated vaccination programs.

GSK also announced new results from the clinical trial assessing the use of Pandemrix in children and adolescents aged 3 to 17 years of age.

The ongoing trial shows that after the first dose of adjuvanted vaccine, a strong immune response was demonstrated in all age groups. The immune response elicited by Pandemrix exceeded the immunogenicity criteria, as defined by international licensing authorities for a pandemic influenza vaccine.

"These results complete GSK's initial post first dose data across all age ranges, from infants through to the elderly. In response to discussions with regulatory authorities and public health authorities, GSK has conducted a clinical program designed to provide data in all age groups," said Jean Stephenne, president of GSK Biologicals. "We are making this information available in as short a time as possible. This allows authorities to have a more complete understanding of how the vaccine can be used in all age groups."

Further information on GSK's development of a vaccine to protect against pandemic 2009, including explanation of the vaccine development process and background information on adjuvants is available on: