GlaxoSmithKline: H1N1 Has Similar Tolerability To H5N1

LONDON -(Dow Jones)- GlaxoSmithKline PLC (GSK), a research-based pharmaceutical and healthcare company, said Friday that data to date demonstrates that the H1N1 adjuvanted vaccine has a similar tolerability profile to GSK’s previously EMEA approved H5N1 adjuvanted vaccine.

MAIN FACTS:

-To date, more than 150,000 people have received GSK's pandemic H1N1 vaccine, Pandemrix, as part of Government initiated vaccination programmes across Europe which commenced last week.

-Additionally, over 2,000 people have received Pandemrix in clinical trials which are ongoing.

-Preliminary results from the first paediatric clinical trial assessing Pandemrix in children aged six-36 months, which is ongoing, shows that after a first dose of adjuvanted vaccine, a strong response was demonstrated which exceeds the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine.

-Vaccine in this trial contains a half dose of H1N1 antigen (1.9 μg) and a half dose of adjuvant, as compared to the adult vaccine.

-Paediatric trial, which is taking place in Spain, involves 200 children aged six-36 months, and has been designed to evaluate the tolerability and immunogenicity of Pandemrix.

-The tolerability of the vaccine in paediatric trial has been shown to be similar to that in the H5N1 clinical trial programme.

 
-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com 
 

(END) Dow Jones Newswires

October 23, 2009 08:28 ET (12:28 GMT)

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