GlaxoSmithKline (GSK) has announced the completion of patient enrolment for the first clinical study of its adjuvanted H1N1 (swine flu) pandemic vaccine.
The first trial, conducted in Germany, will assess the immune response as well as tolerability and other safety aspects of the vaccine in healthy adults. Initial data is expected to be available in September.
GSK Biologicals head of global clinical R&D and chief medical officer Dr Thomas Breuer said that GSK was making good progress.
“Enrolment into the first study has been completed and in total, GSK will conduct 16 clinical trials of its pandemic vaccine in over 9,000 individuals across Europe, Canada and the US,” Breuer said.
The GSK vaccines use the antigen of the recently isolated pandemic (H1N1) 2009 influenza strain and also contain GSK’s proprietary adjuvant system AS03.
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