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Company has started clinical development program
for its adjuvanted pandemic vaccine
GSK has issued an update on its progress to develop a vaccine
against the Pandemic (H1N1) 2009 influenza virus.
The company has also commenced the clinical development program
for its adjuvanted pandemic vaccine.
Reportedly, the first clinical trial being conducted in Germany,
will assess the use of the vaccine in healthy adults. Initial data
is expected to be available for sharing with regulatory
authorities in September.
Further trials of the Pandemic (H1N1) 2009 adjuvanted vaccine
covering infants, children, adults and the elderly will commence
over the coming weeks across Europe, Canada and the US.
The company said that the clinical development program, which has
been designed in close partnership with regulatory authorities,
will evaluate the immune response as well as tolerability and
other safety aspects of the vaccine.
Thomas Breuer, head of Global Clinical R&D and CMO of GSK
Biologicals, said: “GSK is making good progress with the
development of its pandemic vaccine. Enrolment into the first
study has been completed and in total, GSK will conduct 16
clinical trials of its pandemic vaccine in over 9000 individuals
across Europe, Canada and the US.
We continue to work closely with regulators and governments to
assess and develop this vaccine.”
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