Wednesday April 25, 11:53 am Eastern Time
Press Release
SOURCE: GlaxoSmithKline plc

Pediatric Clinical Trial for GlaxoSmithKline Malaria Vaccine To Begin Next
Month in The Gambia

PHILADELPHIA, April 25 /CNW/ -- Screening of children has begun for the
clinical trial of a promising malaria vaccine set to start early next month
in The Gambia, West Africa. The trial is the first of a series of three
planned in The Gambia through a partnership between the Malaria Vaccine
Initiative at PATH (Program for Appropriate Technology in Health, a US-
based nonprofit organization), and GlaxoSmithKline Biologicals (GSK), the
world's largest vaccine manufacturer. The Gambian clinical trial is the
first concrete step in a new partnership between MVI and GSK. The Gambian
unit of the UK's Medical Research Council (MRC) will conduct the trial in
Basse Santa Su, a region in the country's northwest where malaria is
endemic.
Today's announcement comes on Africa Malaria Day, as declared last year by
African Heads of State in the Abuja Declaration and Plan of Action. Malaria
currently infects an estimated 300 to 500 million people. Another 2.3
billion are at risk of the disease, making development of a malaria vaccine
a global health priority. Those most vulnerable to malaria are children
under five years of age and pregnant women.

"These trials are an important step forward in creating a malaria vaccine
for children in Africa," said Regina Rabinovich, MD, Director of the
Malaria Vaccine Initiative at PATH. "Most of the more than one million
people who die of malaria every year are African children under the age of
five." No malaria vaccines have ever been tested and found successful in
children.

"As we mark Africa Malaria Day, we are pleased to announce this major
advance toward the goal of preventing malaria," said Jean Stephenne,
President and General Manager, GlaxoSmithKline Biologicals. "We are
committed to delivering a vaccine that will protect African children from
this devastating disease. These trials are a critical step in that process."

The first trial, which will involve approximately 90 children between six
and eleven years of age, will test the safety and immune response of
GlaxoSmithKline's "RTS,S" vaccine. Pending positive results, two subsequent
trials will test the vaccine in children between one and five years old.
Researchers have already safely tested the vaccine in adult volunteers in
the United States, Belgium, Kenya, and The Gambia. It demonstrated a 70 per
cent efficacy rate in protecting adults in The Gambia against infection
over a short period of time, making it the world's only malaria vaccine
candidate to have shown that level of efficacy.

During the upcoming children's trials, MRC investigators will encourage
families to take the normally recommended malaria prevention measures. They
will closely monitor the children for at least two malaria seasons, which
coincide with the annual rainy season, and treat any child who contracts
malaria. "Investigators at MRC/Gambia will carefully evaluate each child
throughout the trial," said Keith McAdam, Director of MRC/Gambia. "We are
hopeful that the promising results from the adult trial will translate to a
safe vaccine that will protect children for a longer period of time."

Malaria is a parasitic infection transmitted through the bite of the
Anopheles mosquito. Currently, no vaccine is licensed to protect against
malaria. Anti-malarial drugs are available, but the parasite has
consistently developed resistance to them, leaving millions vulnerable to
the disease.

GlaxoSmithKline Biologicals, the world's leading vaccine manufacturer, last
year distributed over 1.1 billion doses of vaccines to 177 countries, an
average of 35 per second. For information, visit GlaxoSmithKline's vaccine
web site at www.worldwidevaccines.com.

GlaxoSmithKline (NYSE: GSK - news) - one of the world's leading research-
based pharmaceutical and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel better, and
live longer.

The Malaria Vaccine Initiative (MVI) at PATH seeks to accelerate the
development of promising malaria vaccines and ensure their availability for
the developing world. For further information about MVI and PATH, visit the
web sites at www.malariavaccine.org and www.path.org.

The Medical Research Council has worked in The Gambia for 50 years and has
developed a strong relationship with the community and the government. As a
result, more than 90 per cent of Gambia's children are immunized against
the major childhood diseases - a slightly higher rate of immunization than
in the United States. For further information about MRC, visit the web site
at www.mrc.ac.uk.

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